Quality Assurance Laboratory, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Quality Assurance Laboratory, Inc.” (first 1980, latest 1980), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | 3 | 3 |
| JSH | Culture Media, Non-Selective And Differential | 3 | 3 |
| JSI | Culture Media, Selective And Differential | 2 | 2 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 2 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
Review panels
- Microbiology (11)
Most recent Quality Assurance Laboratory, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800987 | MUELLER HINTON AGAR | JTZ | 1980-06-02 | 40 |
| K800986 | TRYPTICASE SOY AGAR W5% SHEEP BLOOD | JSG | 1980-06-02 | 40 |
| K800981 | CHOCOLATE AGAR W/ENRICHMENTS | JSG | 1980-05-28 | 35 |
| K800978 | XYLOSE LYSINE DESOXYCHOLATE AGAR | JSH | 1980-05-28 | 35 |
| K800985 | THIOGLYCOLLATE MED. W/O INDICATOR | JSG | 1980-05-23 | 30 |
| K800984 | EOSIN METHYLENE BLUE AGAR, LEVINE | JSH | 1980-05-23 | 30 |
| K800983 | MACCONKEY AGAR | JSI | 1980-05-23 | 30 |
| K800982 | SALMONELLA SHIGELLA AGAR | JSH | 1980-05-23 | 30 |
| K800980 | HEXTOEN ENTERIC AGAR | JSI | 1980-05-23 | 30 |
| K800979 | MUELLER HINTIN AGAR W/5% SHEEP BLOOD | JTZ | 1980-05-23 | 30 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Quality Assurance Laboratory, 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.
- Quality Electrodynamics, LLC (21 510(k)s)
- Quality Electrodynamics (13 510(k)s)
- Quality IN Flow , Ltd. (5 510(k)s)
- Quality Gallant Sdn. Bhd. (4 510(k)s)
- Quality Synthetics Intl, Inc. (4 510(k)s)
- Quality Latex Corp. Sdn Bhd (2 510(k)s)
- The Quality Assurance Service Corp. (1 510(k)s)
- Quality Disposables, Inc. (1 510(k)s)
- Quality Lamp, Inc. (1 510(k)s)
- Quality Latex Products Malaysia Sdn Bhd (1 510(k)s)
- Quality Life Technologies Co;Ltd (1 510(k)s)
- Quality Medical Solusions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quality Assurance Laboratory, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Quality Assurance Laboratory, Inc.” (first 1980, latest 1980), 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 Quality Assurance Laboratory, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quality Assurance Laboratory, Inc. is 30 days.
Which FDA product codes appear under Quality Assurance Laboratory, Inc.?
The most frequent FDA product codes under this applicant name are JSG (Culture Media, Non-Selective And Non-Differential, 3); JSH (Culture Media, Non-Selective And Differential, 3); JSI (Culture Media, Selective And Differential, 2).
Next steps
- See all 11 Quality Assurance Laboratory, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSG, Quality Assurance Laboratory, 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.