Gibco Laboratories Life Technologies, Inc.: FDA clearances and approvals
Gibco Laboratories Life Technologies, Inc. has 67 FDA 510(k) clearances (first 1976, latest 1987), across 22 product codes in 2 review panels. Median 510(k) review time: 22 days.
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 | 18 | 18 |
| JSK | Supplement, Culture Media | 7 | 7 |
| JSH | Culture Media, Non-Selective And Differential | 5 | 5 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 5 | 5 |
| JSG | Culture Media, Non-Selective And Non-Differential | 4 | 4 |
| JSI | Culture Media, Selective And Differential | 4 | 4 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 3 | 3 |
| JSC | Culture Media, General Nutrient Broth | 2 | 2 |
| JSF | Culture Media, Single Biochemical Test | 2 | 2 |
| JSL | Culture Media, Anaerobic Transport | 2 | 2 |
Plus 12 more product codes.
Review panels
- Microbiology (64)
- Pathology (2)
Most recent Gibco Laboratories Life Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871855 | SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM | JSH | 1987-05-26 | 13 |
| K871541 | MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 | JTY | 1987-04-29 | 9 |
| K870134 | MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE | JSJ | 1987-02-04 | 22 |
| K864755 | PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM | JSJ | 1987-01-05 | 31 |
| K864014 | LOMBARD DOWELL AGAR BASE | KZI | 1986-10-29 | 14 |
| K863821 | MUELLER HINTON AGAR W/4%NACL AND OXACILLIN | JTZ | 1986-10-09 | 9 |
| K863820 | DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300 | JSJ | 1986-10-08 | 8 |
| K863289 | CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN | JSJ | 1986-09-03 | 9 |
| K862425 | MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM | JSI | 1986-07-02 | 6 |
| K861058 | SENSITITRE AUTO ID PLATE, AP70 | JTO | 1986-05-20 | 62 |
57 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gibco Laboratories Life Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Gibco Laboratories Life Technologies, Inc. have?
Gibco Laboratories Life Technologies, Inc. has 67 FDA 510(k) clearances (first 1976, latest 1987), across 22 product codes in 2 review panels.
How long does FDA take to clear Gibco Laboratories Life Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Gibco Laboratories Life Technologies, Inc.'s cleared 510(k)s is 22 days.
What devices does Gibco Laboratories Life Technologies, Inc. make?
Its most frequent FDA product codes are JSJ (Culture Media, Selective And Non-Differential, 18); JSK (Supplement, Culture Media, 7); JSH (Culture Media, Non-Selective And Differential, 5).
Has Gibco Laboratories Life Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Gibco Laboratories Life Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 67 Gibco Laboratories Life Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSJ, Gibco Laboratories Life Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.