Carroll Biological Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Carroll Biological Corp.” (first 1983, latest 1983), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | 3 | 3 |
| JSC | Culture Media, General Nutrient Broth | 2 | 2 |
| JSI | Culture Media, Selective And Differential | 2 | 2 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
| JSH | Culture Media, Non-Selective And Differential | 1 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Review panels
- Microbiology (11)
Most recent Carroll Biological Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832243 | CULTURE MEDIUM FOR ANTIMICROBIAL SUS | JTZ | 1983-09-29 | 83 |
| K832620 | TRYPTIC SOY BROTH MEDIA | JSC | 1983-09-12 | 66 |
| K832619 | THIOGLYCOLLATE MEDIUM | JSC | 1983-09-12 | 66 |
| K832618 | BLUE AGAR | JSI | 1983-09-12 | 66 |
| K832617 | XYLOSE LYSINE DEOXYCHOLATE | JSI | 1983-09-12 | 66 |
| K832616 | MACCONKEY AGAR MEDIA | JSH | 1983-09-12 | 66 |
| K832615 | SF BROTH | JSJ | 1983-09-12 | 66 |
| K832614 | SELENITE BROTH | JSJ | 1983-09-12 | 66 |
| K832613 | MANNITOL SALT AGAR | JSJ | 1983-09-12 | 66 |
| K832612 | CHOCOLATE AGAR & THAYER MARTIN AGAR | JTY | 1983-09-12 | 66 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Carroll Biological Corp..
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.
- Carroll Healthcare, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carroll Biological Corp.?
FDA lists 11 510(k) clearances under the applicant name “Carroll Biological Corp.” (first 1983, latest 1983), across 7 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 Carroll Biological Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carroll Biological Corp. is 66 days.
Which FDA product codes appear under Carroll Biological Corp.?
The most frequent FDA product codes under this applicant name are JSJ (Culture Media, Selective And Non-Differential, 3); JSC (Culture Media, General Nutrient Broth, 2); JSI (Culture Media, Selective And Differential, 2).
Next steps
- See all 11 Carroll Biological Corp. clearances with predicates and recalls
- Run predicate analysis for product code JSJ, Carroll Biological Corp.'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.