Data Medical Associates, Inc.: FDA clearances and approvals
Data Medical Associates, Inc. has 111 FDA 510(k) clearances (first 1978, latest 1999), across 47 product codes in 2 review panels. Median 510(k) review time: 35 days.
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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 10 | 10 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 6 | 6 |
| JIY | Photometric Method, Iron (Non-Heme) | 5 | 5 |
| CEK | Biuret (Colorimetric), Total Protein | 4 | 4 |
| CFR | Hexokinase, Glucose | 4 | 4 |
| KHS | Enzymatic, Carbon-Dioxide | 4 | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 3 | 3 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 3 | 3 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 3 | 3 |
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
Plus 37 more product codes.
Review panels
- Clinical Chemistry (109)
- Hematology (1)
Most recent Data Medical Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993098 | HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 | JIX | 1999-10-08 | 22 |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | CDT | 1997-05-29 | 63 |
| K961919 | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | JPZ | 1996-07-01 | 45 |
| K955796 | IRON CALIBRATOR & CALIBRATION VERIFICATION SET | JJX | 1996-02-29 | 69 |
| K955302 | SERUM BICARBONATE/CARBON DIOXIDE | KHS | 1996-02-29 | 101 |
| K955300 | TOTAL BILIRUBIN PROCEDURE | CIG | 1995-12-20 | 30 |
| K952437 | DMA GLUCOSE HEXOKINASE U.V. PROCEDURE | CFR | 1995-10-03 | 131 |
| K946161 | DMA TOTAL CHOLESTEROL PROCEDURE | CHH | 1995-08-23 | 247 |
| K946354 | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | JMO | 1995-05-08 | 129 |
| K946355 | DMA ALBUMIN PROCEDURE | CIX | 1995-03-01 | 61 |
101 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Data Medical Associates, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Data Medical Associates, Inc. have?
Data Medical Associates, Inc. has 111 FDA 510(k) clearances (first 1978, latest 1999), across 47 product codes in 2 review panels.
How long does FDA take to clear Data Medical Associates, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Data Medical Associates, Inc.'s cleared 510(k)s is 35 days.
What devices does Data Medical Associates, Inc. make?
Its most frequent FDA product codes are CIG (Diazo Colorimetry, Bilirubin, 10); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 6); JIY (Photometric Method, Iron (Non-Heme), 5).
Has Data Medical Associates, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Data Medical Associates, Inc. Related entities may recall under other names.
Next steps
- See all 111 Data Medical Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Data Medical Associates, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.