American Laboratory Supply, Inc.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “American Laboratory Supply, Inc.” (first 1979, latest 1985), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 10 | 10 |
| JSJ | Culture Media, Selective And Non-Differential | 10 | 10 |
| JSG | Culture Media, Non-Selective And Non-Differential | 7 | 7 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 | 3 |
| JSH | Culture Media, Non-Selective And Differential | 2 | 2 |
| JSC | Culture Media, General Nutrient Broth | 1 | 1 |
| JSD | Culture Media, Selective Broth | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
| KZI | Culture Media, Enriched | 1 | 1 |
Review panels
- Microbiology (36)
Most recent American Laboratory Supply, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852578 | CLED AGAR | JSH | 1985-07-12 | 24 |
| K844933 | BILE ESCULIN AGAR | JSI | 1985-02-27 | 70 |
| K844932 | MALT AGAR | JSJ | 1985-02-27 | 70 |
| K844931 | MYCOLOGICAL AGAR W/ANTIBIOTICS | JSJ | 1985-02-27 | 70 |
| K844930 | BRILLANT GREEN AGAR | JSI | 1985-02-27 | 70 |
| K844929 | INHIBITORY MOLD AGAR | JSJ | 1985-02-27 | 70 |
| K844934 | AZIDE AGAR W/5% SHEEP BLOOD | JSI | 1985-02-25 | 68 |
| K820562 | CAMPYLOBACTER SELECTIVE MEDIUM | JSJ | 1982-03-19 | 17 |
| K820561 | SABOURAUD DEXTROSE AGAR | JSJ | 1982-03-19 | 17 |
| K820560 | PHENYLETHANOL AGAR W/5% SHEEP BLOOD | JSJ | 1982-03-19 | 17 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Laboratory Supply, 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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Sterilizer Co. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Laboratory Supply, Inc.?
FDA lists 36 510(k) clearances under the applicant name “American Laboratory Supply, Inc.” (first 1979, latest 1985), 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 American Laboratory Supply, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Laboratory Supply, Inc. is 24 days.
Which FDA product codes appear under American Laboratory Supply, Inc.?
The most frequent FDA product codes under this applicant name are JSI (Culture Media, Selective And Differential, 10); JSJ (Culture Media, Selective And Non-Differential, 10); JSG (Culture Media, Non-Selective And Non-Differential, 7).
Next steps
- See all 36 American Laboratory Supply, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSI, American Laboratory Supply, 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.