Microdiagnostics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Microdiagnostics, Inc.” (first 1991, latest 2001), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 3 | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 2 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
Review panels
- Clinical Toxicology (10)
Most recent Microdiagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011952 | DRUGS OF ABUSE MULTI-TEST STRIP | DKZ | 2001-10-25 | 126 |
| K991516 | MICRO-STRIP FOR MARIJUANA METABOLITES | LDJ | 1999-08-05 | 97 |
| K991505 | MICRO-STRIP FOR PHENCYCLIDINE METABOLITES | LCM | 1999-08-05 | 98 |
| K981388 | MICRO-STRIP FOR COCAINE METABOLITES | DIO | 1998-05-29 | 43 |
| K974611 | MICRO-STRIP FOR AMPHETAMINE METABOLITES | DKZ | 1998-03-20 | 99 |
| K973761 | MICRO-STRIP FOR OPIATE METABOLITES | DJG | 1997-12-24 | 83 |
| K932304 | MICRO EIA FOR AMPHETAMINE METABOLITES | DKZ | 1993-12-07 | 209 |
| K923468 | MICRO EIA FOR OPIATE METABOLITES | DJG | 1992-09-15 | 63 |
| K914533 | MICRO EIA FOR COCAINE METABOLITES | DIO | 1991-12-10 | 60 |
| K914490 | MICRO EIA FOR MARIJUANA METABOLITES | LDJ | 1991-11-29 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Microdiagnostics, 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 Microdiagnostics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Microdiagnostics, Inc.” (first 1991, latest 2001), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Microdiagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microdiagnostics, Inc. is 90 days.
Which FDA product codes appear under Microdiagnostics, Inc.?
The most frequent FDA product codes under this applicant name are DKZ (Enzyme Immunoassay, Amphetamine, 3); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 2); DJG (Enzyme Immunoassay, Opiates, 2).
Next steps
- See all 10 Microdiagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, Microdiagnostics, 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.