Dms Laboratories: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Dms Laboratories” (first 1982, latest 1983), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 13 | 13 |
| JSC | Culture Media, General Nutrient Broth | 3 | 3 |
| JSE | Culture Media, Multiple Biochemical Test | 1 | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 | 1 |
| JSN | Culture Media, Propagating Transport | 1 | 1 |
| JSS | Kit, Identification, Enterobacteriaceae | 1 | 1 |
| JTS | Stains, Microbiologic | 1 | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (22)
Most recent Dms Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K831187 | TRP | JTO | 1983-05-09 | 27 |
| K831186 | RAPID NFT | JSN | 1983-05-09 | 27 |
| K830437 | CHS | JSC | 1983-03-17 | 36 |
| K823102 | AGAR P | JSJ | 1982-12-03 | 44 |
| K821038 | FAST VIOLET B | JTS | 1982-05-27 | 44 |
| K813613 | RAPID CH | JTO | 1982-02-22 | 55 |
| K813612 | RAPID ZYME | JTO | 1982-02-22 | 55 |
| K820213 | SALINE SOLUTION | JTO | 1982-02-12 | 17 |
| K820212 | OXI | JTO | 1982-02-12 | 17 |
| K820211 | NINHYDRIN | JTO | 1982-02-12 | 17 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dms Laboratories.
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 Dms Laboratories?
FDA lists 23 510(k) clearances under the applicant name “Dms Laboratories” (first 1982, latest 1983), across 9 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 Dms Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dms Laboratories is 27 days.
Which FDA product codes appear under Dms Laboratories?
The most frequent FDA product codes under this applicant name are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 13); JSC (Culture Media, General Nutrient Broth, 3); JSE (Culture Media, Multiple Biochemical Test, 1).
Next steps
- See all 23 Dms Laboratories clearances with predicates and recalls
- Run predicate analysis for product code JTO, Dms Laboratories'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.