Ortho Diagnostic Systems, Inc.: FDA filings under this applicant name
FDA lists 126 510(k) clearances under the applicant name “Ortho Diagnostic Systems, Inc.” (first 1981, latest 1997), across 55 product codes in 7 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under QuidelOrtho, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 16 | 16 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 13 | 13 |
| GJT | Plasma, Coagulation Factor Deficient | 5 | 5 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 | 5 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 5 | 5 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 4 | 4 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 4 | 4 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 3 | 3 |
| GJS | Test, Time, Prothrombin | 3 | 3 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 3 | 3 |
Plus 45 more product codes.
Review panels
- Hematology (51)
- Microbiology (41)
- Clinical Chemistry (21)
- Immunology (5)
- Clinical Toxicology (3)
- Obstetrics and Gynecology (2)
- Pathology (1)
Most recent Ortho Diagnostic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951459 | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE | GKZ | 1997-07-14 | 837 |
| K951632 | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) | GKZ | 1997-03-06 | 699 |
| K964754 | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE | GKZ | 1997-01-22 | 56 |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | GIS | 1996-11-29 | 63 |
| K951100 | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) | GKZ | 1996-05-13 | 430 |
| K950625 | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) | GKZ | 1996-05-13 | 458 |
| K950568 | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) | GKZ | 1996-05-13 | 460 |
| K950482 | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) | GKZ | 1996-05-10 | 462 |
| K935720 | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM | GKZ | 1996-05-09 | 891 |
| K954570 | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM | GKZ | 1996-04-30 | 211 |
116 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ortho Diagnostic Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ortho Diagnostic Systems, Inc. (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ortho Development Corp. (64 510(k)s)
- Ortho Diagnostics, Inc. (24 510(k)s)
- Ortho Tec, LLC (22 510(k)s)
- Ortho Clinical Diagnostics (16 510(k)s)
- Ortho Pharmaceutical Corp. (9 510(k)s)
- Ortho Source (9 510(k)s)
- Ortho Organizers, Inc. (8 510(k)s)
- Ortho Kinetics Corp. (7 510(k)s)
- Ortho Instruments (6 510(k)s)
- Ortho Kinematics, Inc. (6 510(k)s)
- Ortho Solutions Limited (6 510(k)s)
- Ortho Pared Instruments, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ortho Diagnostic Systems, Inc.?
FDA lists 126 510(k) clearances under the applicant name “Ortho Diagnostic Systems, Inc.” (first 1981, latest 1997), across 55 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ortho Diagnostic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho Diagnostic Systems, Inc. is 84 days.
Which FDA product codes appear under Ortho Diagnostic Systems, Inc.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 16); JJY (Multi-Analyte Controls, All Kinds (Assayed), 13); GJT (Plasma, Coagulation Factor Deficient, 5).
Next steps
- See all 126 Ortho Diagnostic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Ortho Diagnostic Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.