Microgenics Corp.: FDA filings under this applicant name
FDA lists 126 510(k) clearances under the applicant name “Microgenics Corp.” (first 1985, latest 2024), plus 2 De Novo decisions, across 45 product codes in 3 review panels. Median 510(k) review time under this name: 76 days. Since 2017 the median was 134 days, against 201 days for all cleared 510(k)s in the same product codes. 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 Thermo Fisher Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 146 |
| 2013 | 4 | 228 |
| 2014 | 0 | — |
| 2015 | 1 | 225 |
| 2016 | 0 | — |
| 2017 | 2 | 100 |
| 2018 | 3 | 55 |
| 2019 | 2 | 150 |
| 2020 | 0 | — |
| 2021 | 1 | 91 |
| 2022 | 1 | 373 |
| 2023 | 2 | 197 |
| 2024 | 2 | 131 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Microgenics Corp. took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 201 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 13 | 13 |
| KXT | Enzyme Immunoassay, Digoxin | 9 | 9 |
| DKZ | Enzyme Immunoassay, Amphetamine | 8 | 8 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 7 | 7 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 6 | 6 |
| DKB | Calibrators, Drug Mixture | 6 | 6 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 6 | 6 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 6 | 6 |
| DLJ | Calibrators, Drug Specific | 5 | 5 |
| LAS | Drug Specific Control Materials | 5 | 5 |
Plus 35 more product codes.
Review panels
- Clinical Toxicology (102)
- Clinical Chemistry (24)
- Hematology (2)
Most recent Microgenics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent Kit | JXM | 2024-12-11 | 29 |
| K240670 | DRI Ecstasy Plus Assay | DKZ | 2024-10-30 | 233 |
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | LFH | 2023-11-17 | 221 |
| K231007 | CEDIA Heroin Metabolite (6-AM) Assay | DJG | 2023-09-27 | 173 |
| K213875 | DRI TM Tricyclics Serum Tox Assay | LFH | 2022-12-21 | 373 |
| K211973 | DRI Cocaine Metabolite Assay | DIO | 2021-09-24 | 91 |
| K192943 | CEDIA Heroin Metabolite (6-AM) assay | DJG | 2019-12-16 | 59 |
| K190968 | CEDIA Benzodiazepine Assay | JXM | 2019-12-09 | 241 |
| K181499 | DRI Cocaine Metabolite Assay | DIO | 2018-07-06 | 29 |
| K173963 | DRI Benzodiazepine Assay | JXM | 2018-02-21 | 55 |
116 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180030 | De Novo | Plazomicin Test System, Immunoassay | 2018-11-19 |
| DEN040008 | De Novo | Sirolimus Test System | 2004-07-28 |
Recalls
14 product recalls in 13 recall events; 2 initiated in the last five years. Most recent: 2025-10-01.
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 Microgenics Corp.?
FDA lists 126 510(k) clearances under the applicant name “Microgenics Corp.” (first 1985, latest 2024), plus 2 De Novo decisions, across 45 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 Microgenics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microgenics Corp. is 76 days. Since 2017: 134 days, versus 201 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Microgenics Corp.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 13); KXT (Enzyme Immunoassay, Digoxin, 9); DKZ (Enzyme Immunoassay, Amphetamine, 8).
Next steps
- See all 126 Microgenics Corp. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Microgenics Corp.'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.