Orion Diagnostica, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Orion Diagnostica, Inc.” (first 1980, latest 1994), across 24 product codes in 3 review panels. Median 510(k) review time under this name: 42 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 3 | 3 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 2 | 2 |
| GON | Antigen, Cf (Including Cf Control), Rubella | 2 | 2 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| DAH | Gamma Globulin, Antigen, Antiserum, Control | 1 | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| EGD | Wax, Dental, Intraoral | 1 | 1 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 | 1 |
Plus 14 more product codes.
Review panels
- Microbiology (22)
- Immunology (5)
- Dental (1)
Most recent Orion Diagnostica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942286 | DIARLEX ROTA-ADENO | LIQ | 1994-12-14 | 236 |
| K914892 | SALIVA-STIM | EGD | 1992-09-02 | 307 |
| K904655 | PYLORISET | LYR | 1991-10-21 | 374 |
| K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M | DFT | 1988-10-27 | 24 |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | DAH | 1988-10-27 | 30 |
| K884075 | IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN | DDG | 1988-10-19 | 22 |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | CZP | 1988-10-19 | 23 |
| K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST | GOD | 1987-06-04 | 191 |
| K871196 | RHEUMA-CHECK ENZYME IMMUNOASSAY TEST | DHR | 1987-05-06 | 43 |
| K862475 | RESPIRASTICK ENZYME IMMUNOASSAY TEST | GTY | 1986-09-16 | 78 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orion Diagnostica, 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 Orion Diagnostica, Inc. (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNX)
- J1460 — Injection, gamma globulin, intramuscular, 1 cc (via DAH)
- J1560 — Injection, gamma globulin, intramuscular, over 10 cc (via DAH)
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.
- Orion Life Systems, Inc. (33 510(k)s)
- Orion Corp. (21 510(k)s)
- Orion Corporation Soredex (4 510(k)s)
- Orion Diagnostica, Div. Orion Corp. (4 510(k)s)
- Orion Diagnostica, OY (4 510(k)s)
- Orion Biotech, Inc. (1 510(k)s)
- Orion Industries (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orion Diagnostica, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Orion Diagnostica, Inc.” (first 1980, latest 1994), across 24 product codes in 3 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 Orion Diagnostica, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orion Diagnostica, Inc. is 42 days.
Which FDA product codes appear under Orion Diagnostica, Inc.?
The most frequent FDA product codes under this applicant name are LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus, 3); GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33, 2); GON (Antigen, Cf (Including Cf Control), Rubella, 2).
Next steps
- See all 28 Orion Diagnostica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIQ, Orion Diagnostica, 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.