Reference Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Reference Diagnostics, Inc.” (first 1990, latest 2006), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | 5 | 5 |
| MRR | System, Test, Low Density, Lipoprotein | 4 | 4 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 2 |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 2 | 2 |
| LBR | Ldl & Vldl Precipitation, Hdl | 2 | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 1 |
Review panels
- Clinical Chemistry (14)
- Immunology (3)
Most recent Reference Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053291 | FERRITIN CALIBRATOR SET, CATALOG NO. 8203 | JIT | 2006-03-13 | 108 |
| K053211 | RDI HSFERRITIN KIT | DBF | 2006-03-13 | 117 |
| K052148 | TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET | JIT | 2005-11-09 | 93 |
| K030044 | EXTENDED RANGE HS CRP KIT, CAT NO:9200 | DCK | 2003-09-30 | 267 |
| K030772 | RDI EXTENDED RANGE CRP CALIBRATOR SET | JIT | 2003-04-11 | 31 |
| K021609 | RDI HS CRP KIT | DCK | 2002-06-27 | 42 |
| K021607 | RDI HS CRP CALIBRATOR SET | JIT | 2002-06-27 | 42 |
| K000783 | DIRECT TIBC CALIBRATOR | JIT | 2000-05-04 | 55 |
| K000781 | DIRECT TIBC KIT | JMO | 2000-05-02 | 53 |
| K990216 | MAGNETIC TIBC KIT | JMO | 1999-02-16 | 25 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Reference Diagnostics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Reference Diagnostics, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Reference Diagnostics, Inc.” (first 1990, latest 2006), across 7 product codes in 2 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 Reference Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reference Diagnostics, Inc. is 62 days.
Which FDA product codes appear under Reference Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JIT (Calibrator, Secondary, 5); MRR (System, Test, Low Density, Lipoprotein, 4); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 2).
Next steps
- See all 17 Reference Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIT, Reference Diagnostics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.