Analytab Products, Inc.: FDA clearances and approvals
Analytab Products, Inc. has 5 FDA 510(k) clearances (first 1981, latest 1991), across 2 product codes in 1 review panel. Median 510(k) review time: 31 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 3 | 3 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 2 | 2 |
Review panels
- Microbiology (5)
Most recent Analytab Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912965 | API UNISCEPT KB | JWY | 1991-09-06 | 60 |
| K912964 | API UNISCEPT MIC/UNISCEPT MICRO-MIC | JWY | 1991-08-29 | 52 |
| K861408 | MODIFIED UNISCEPT KB LABELING AMENDMENT | JWY | 1986-05-16 | 31 |
| K812877 | PENASE | JTO | 1981-10-26 | 12 |
| K812862 | API GERM TUBE | JTO | 1981-10-26 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Analytab Products, 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 Analytab Products, Inc. have?
Analytab Products, Inc. has 5 FDA 510(k) clearances (first 1981, latest 1991), across 2 product codes in 1 review panel.
How long does FDA take to clear Analytab Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Analytab Products, Inc.'s cleared 510(k)s is 31 days.
What devices does Analytab Products, Inc. make?
Its most frequent FDA product codes are JWY (Manual Antimicrobial Susceptibility Test Systems, 3); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 2).
Has Analytab Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Analytab Products, Inc. Related entities may recall under other names.
Next steps
- See all 5 Analytab Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Analytab Products, 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.