Difco Laboratories, Inc.: FDA clearances and approvals
Difco Laboratories, Inc. has 121 FDA 510(k) clearances (first 1979, latest 1997), across 35 product codes in 4 review panels. Median 510(k) review time: 38 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 |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 41 | 41 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 34 | 34 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 | 3 |
| JSF | Culture Media, Single Biochemical Test | 3 | 3 |
| JTW | System, Transport, Aerobic | 3 | 3 |
| KIR | Cells, Animal And Human, Cultured | 3 | 3 |
| MDB | System, Blood Culturing | 3 | 3 |
| LED | Stains, Chemical Solution | 2 | 2 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 | 2 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
Plus 25 more product codes.
Review panels
- Microbiology (110)
- Pathology (6)
- Immunology (2)
- Clinical Chemistry (1)
Most recent Difco Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971211 | DISPENS-O-DISC SPARFLOXACIN | JTN | 1997-04-14 | 18 |
| K971120 | DISPENS-O-DISC (TM) LEVOFLOXACIN | JTN | 1997-04-14 | 18 |
| K963508 | DISPENS-O-DISC MEROPENEM | JTN | 1996-09-26 | 23 |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | JTW | 1996-04-26 | 36 |
| K954783 | DRYSLIDE CARTARRHALIS | JTO | 1996-02-06 | 112 |
| K954784 | DRYSIDE NEISSERIA | LTS | 1996-01-30 | 105 |
| K953129 | ESP CULTURE SYSTEM - MYCO | MDB | 1995-12-26 | 173 |
| K950706 | DRYSLIDE COAGULASE | JTL | 1995-05-16 | 90 |
| K944275 | DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. | JTN | 1994-12-19 | 111 |
| K941016 | DISPENS-O-DISC(TM) NITROCEFIN | JTO | 1994-06-30 | 119 |
111 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Difco Laboratories, 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 Difco Laboratories, Inc. have?
Difco Laboratories, Inc. has 121 FDA 510(k) clearances (first 1979, latest 1997), across 35 product codes in 4 review panels.
How long does FDA take to clear Difco Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Difco Laboratories, Inc.'s cleared 510(k)s is 38 days.
What devices does Difco Laboratories, Inc. make?
Its most frequent FDA product codes are JTN (Susceptibility Test Discs, Antimicrobial, 41); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 34); GTZ (Antisera, All Groups, Streptococcus Spp., 3).
Has Difco Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Difco Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 121 Difco Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTN, Difco Laboratories, 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.