Micro-Media Systems, Inc.: FDA clearances and approvals
Micro-Media Systems, Inc. has 7 FDA 510(k) clearances (first 1977, latest 1995), across 6 product codes in 1 review panel. Median 510(k) review time: 62 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 2 | 2 |
| JSE | Culture Media, Multiple Biochemical Test | 1 | 1 |
| JSP | Kit, Anaerobic Identification | 1 | 1 |
| JSS | Kit, Identification, Enterobacteriaceae | 1 | 1 |
| JSW | Kit, Identification, Glucose Nonfermenter | 1 | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 | 1 |
Review panels
- Microbiology (7)
Most recent Micro-Media Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953422 | FOX FASTIDIOUS TEST PANELS | JWY | 1995-10-07 | 92 |
| K945997 | MODIFIED FOX EXTRA GRAM POSITIVE | JWY | 1995-02-16 | 132 |
| K823738 | GRAM NEGATIVE BACTERIAL IDENTIF- PANELS | JTO | 1983-01-07 | 25 |
| K801547 | TEST PANEL FOR PRESUMP. ID/BACT. ORG | JSP | 1980-09-09 | 64 |
| K791991 | STREP-SPEC | JSS | 1979-11-13 | 41 |
| K770746 | PANEL, IDENTIFICATION, STREP, MICRO-ID | JSE | 1977-06-23 | 62 |
| K770745 | PANEL, GNF, MICRO-ID | JSW | 1977-06-23 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Micro-Media Systems, 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 Micro-Media Systems, Inc. have?
Micro-Media Systems, Inc. has 7 FDA 510(k) clearances (first 1977, latest 1995), across 6 product codes in 1 review panel.
How long does FDA take to clear Micro-Media Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Micro-Media Systems, Inc.'s cleared 510(k)s is 62 days.
What devices does Micro-Media Systems, Inc. make?
Its most frequent FDA product codes are JWY (Manual Antimicrobial Susceptibility Test Systems, 2); JSE (Culture Media, Multiple Biochemical Test, 1); JSP (Kit, Anaerobic Identification, 1).
Has Micro-Media Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Micro-Media Systems, Inc. Related entities may recall under other names.
Next steps
- See all 7 Micro-Media Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Micro-Media Systems, 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.