Carr-Scarborough Microbiologicals, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Carr-Scarborough Microbiologicals, Inc.” (first 1979, latest 1994), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 26 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 | 10 | 10 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 2 | 2 |
| HYI | Iodine, Grams | 1 | 1 |
| IDC | Acridine Orange | 1 | 1 |
| JSF | Culture Media, Single Biochemical Test | 1 | 1 |
| JSI | Culture Media, Selective And Differential | 1 | 1 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 1 | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 1 |
| JTS | Stains, Microbiologic | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
Plus 4 more product codes.
Review panels
- Microbiology (20)
- Pathology (3)
Most recent Carr-Scarborough Microbiologicals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944554 | BRAIN HEART INFUSION AGAR | JSO | 1994-10-04 | 18 |
| K941985 | MUELLER HINTON AGAR W/OXACILLIN | JTZ | 1994-08-24 | 121 |
| K905472 | LAP DISCS | JTO | 1991-02-27 | 83 |
| K905666 | M. CAT. BUTYRATE DISC | JTO | 1991-02-26 | 70 |
| K891476 | C. ALBICANS SCREEN | JXC | 1989-04-12 | 27 |
| K882636 | ALN DISCS | JTO | 1989-02-16 | 234 |
| K882630 | PRO DISCS | JTO | 1989-02-16 | 234 |
| K863216 | NEIS NZY | JTO | 1986-09-15 | 26 |
| K860301 | RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE | JTO | 1986-02-06 | 9 |
| K860302 | PYR DISCS | JTO | 1986-02-05 | 8 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Carr-Scarborough Microbiologicals, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Carr-Scarborough Microbiologicals, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Carr-Scarborough Microbiologicals, Inc.” (first 1979, latest 1994), across 14 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Carr-Scarborough Microbiologicals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carr-Scarborough Microbiologicals, Inc. is 26 days.
Which FDA product codes appear under Carr-Scarborough Microbiologicals, Inc.?
The most frequent FDA product codes under this applicant name are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 10); LIB (Device, General Purpose, Microbiology, Diagnostic, 2); HYI (Iodine, Grams, 1).
Next steps
- See all 24 Carr-Scarborough Microbiologicals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTO, Carr-Scarborough Microbiologicals, 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, 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.