Mds Laboratories, Inc.: FDA clearances and approvals
Mds Laboratories, Inc. has 21 FDA 510(k) clearances (first 1982, latest 1987), across 11 product codes in 1 review panel. Median 510(k) review time: 154 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 |
|---|---|---|---|
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 4 | 4 |
| JSG | Culture Media, Non-Selective And Non-Differential | 3 | 3 |
| JSF | Culture Media, Single Biochemical Test | 2 | 2 |
| JSI | Culture Media, Selective And Differential | 2 | 2 |
| JSJ | Culture Media, Selective And Non-Differential | 2 | 2 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 2 | 2 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 2 | 2 |
| JSH | Culture Media, Non-Selective And Differential | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| KZI | Culture Media, Enriched | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (21)
Most recent Mds Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864256 | TRYPTONE WATER (1%) | JSF | 1987-03-31 | 154 |
| K864255 | TRYPTICASE SOY BROTH | JSG | 1987-03-31 | 154 |
| K864254 | THIOGLYCOLLATE BROTH | JSG | 1987-03-31 | 154 |
| K864253 | THAYER MARTIN AGAR | JTY | 1987-03-31 | 154 |
| K864252 | THAYER-MARTIN JEMBEC | JTY | 1987-03-31 | 154 |
| K864251 | SELENITE F. BROTH | JSJ | 1987-03-31 | 154 |
| K864250 | SABOURAUD DEXTROSE AGAR | JSJ | 1987-03-31 | 154 |
| K864249 | NORMAL SALINE STERILE | LIB | 1987-03-31 | 154 |
| K864248 | MUELLER HINTON AGAR - SUPPLEMENTED | JTZ | 1987-03-31 | 154 |
| K864247 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | JTZ | 1987-03-31 | 154 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mds Laboratories, 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 Mds Laboratories, Inc. have?
Mds Laboratories, Inc. has 21 FDA 510(k) clearances (first 1982, latest 1987), across 11 product codes in 1 review panel.
How long does FDA take to clear Mds Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mds Laboratories, Inc.'s cleared 510(k)s is 154 days.
What devices does Mds Laboratories, Inc. make?
Its most frequent FDA product codes are JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth, 4); JSG (Culture Media, Non-Selective And Non-Differential, 3); JSF (Culture Media, Single Biochemical Test, 2).
Has Mds Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mds Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 21 Mds Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTZ, Mds Laboratories, 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.