Microtech Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Microtech Medical Systems, Inc.” (first 1985, latest 1995), plus 1 PMA decision, across 6 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 5 | 5 |
| JSS | Kit, Identification, Enterobacteriaceae | 2 | 2 |
| JTC | Device, Microtiter Diluting/Dispensing | 2 | 2 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 2 | 2 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 1 | 0 |
| LTW | Susceptibility Test Cards, Antimicrobial | 1 | 1 |
Review panels
- Microbiology (13)
Most recent Microtech Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935485 | FAS FASTIDIOUS MIC PANEL | JWY | 1995-02-16 | 458 |
| K901598 | FASTIDIOUS MIC PANEL | JWY | 1990-11-08 | 217 |
| K896332 | SUPPLEMENT TO ANAEROBIC MIC PANEL | JWY | 1990-02-05 | 95 |
| K884831 | ANAEROBIC MIC PANEL | JWY | 1989-03-27 | 129 |
| K863847 | MIC - CONCEPT(TM) RX-2 | JWY | 1986-12-18 | 79 |
| K861774 | QUADRA-TITER (TM) I.D. (MODIFICATION) | JSS | 1986-05-20 | 13 |
| K860208 | QUADRA-TITER I.D. | JSS | 1986-03-03 | 40 |
| K852613 | MIC-CONCEPT SYSTEM | LTW | 1985-09-20 | 93 |
| K853745 | MIC-CONCEPT VIEWBOX | LIB | 1985-09-19 | 10 |
| K850725 | QUADRA TITER MICRO PLATES | LIB | 1985-04-30 | 67 |
2 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N50487 | PMA | MIC TEST PANELS | 1977-05-09 |
Recalls
openFDA lists no recalls under a recalling firm named Microtech Medical Systems, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Microtech (2 510(k)s)
- Microtech Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microtech Medical Systems, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Microtech Medical Systems, Inc.” (first 1985, latest 1995), plus 1 PMA decision, across 6 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 Microtech Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microtech Medical Systems, Inc. is 73 days.
Which FDA product codes appear under Microtech Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 5); JSS (Kit, Identification, Enterobacteriaceae, 2); JTC (Device, Microtiter Diluting/Dispensing, 2).
Next steps
- See all 12 Microtech Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Microtech Medical Systems, 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.