General Diagnostics: FDA clearances and approvals
General Diagnostics has 39 FDA 510(k) clearances (first 1976, latest 1988), across 23 product codes in 4 review panels. Median 510(k) review time: 34 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 |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 12 | 12 |
| DIF | Drug Mixture Control Materials | 3 | 3 |
| GJA | Test, Thrombin Time | 3 | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIJ | Saccharogenic, Amylase | 1 | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 | 1 |
Plus 13 more product codes.
Review panels
- Microbiology (13)
- Hematology (12)
- Clinical Toxicology (8)
- Clinical Chemistry (6)
Most recent General Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882663 | BARBITURATE ENZYME IMMUNOASSAY KIT | DIS | 1988-09-19 | 84 |
| K872882 | CANNABINOID ENZYME IMMUNOASSAY KIT | LDJ | 1987-11-03 | 104 |
| K871305 | COCAINE METABOLITE ENZYME IMMUNOASSAY KIT | DIO | 1987-06-05 | 65 |
| K864993 | QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE | DIS | 1987-03-31 | 99 |
| K863877 | BENZODIAZEPINE ENZYME IMMUNOASSAY KIT | JXM | 1987-03-12 | 157 |
| K842307 | GENERAL DIAG. CEFONICID 30MCG ANTIMIC | JTN | 1984-07-20 | 38 |
| K841465 | GENERAL DIAGNOSTICS PLATELET ANTIBODY | LLG | 1984-07-02 | 84 |
| K833709 | CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK | JTN | 1983-12-30 | 71 |
| K832653 | CEFUROXIME 30MCG. SUSCEP DISK | JTN | 1983-10-14 | 67 |
| K831179 | CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP | JTN | 1983-05-09 | 28 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named General Diagnostics.
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 General Diagnostics have?
General Diagnostics has 39 FDA 510(k) clearances (first 1976, latest 1988), across 23 product codes in 4 review panels.
How long does FDA take to clear General Diagnostics's 510(k)s?
The median time from FDA receipt to decision across General Diagnostics's cleared 510(k)s is 34 days.
What devices does General Diagnostics make?
Its most frequent FDA product codes are JTN (Susceptibility Test Discs, Antimicrobial, 12); DIF (Drug Mixture Control Materials, 3); GJA (Test, Thrombin Time, 3).
Has General Diagnostics had device recalls?
openFDA lists no recalls under a recalling firm name matching General Diagnostics. Related entities may recall under other names.
Next steps
- See all 39 General Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JTN, General Diagnostics'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.