Ab Biodisk: FDA filings under this applicant name
FDA lists 64 510(k) clearances under the applicant name “Ab Biodisk” (first 1991, latest 2008), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 61 | 61 |
| LTX | Discs, Elution | 2 | 2 |
| NGZ | Susceptibility Test Plate, Antifungal | 1 | 1 |
Review panels
- Microbiology (64)
Most recent Ab Biodisk 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081325 | ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML | JWY | 2008-07-24 | 73 |
| K052366 | ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA | JWY | 2005-10-13 | 45 |
| K042392 | DAPTOMYCIN | JWY | 2004-12-13 | 102 |
| K042390 | ETEST FOR GEMIFLOXACIN | JWY | 2004-11-19 | 78 |
| K040560 | ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING | NGZ | 2004-07-27 | 146 |
| K021445 | ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE | JWY | 2002-06-06 | 31 |
| K020748 | ETEST ERTAPENEM | JWY | 2002-04-29 | 53 |
| K010363 | ETEST MEROPENEM | JWY | 2001-04-09 | 61 |
| K002139 | ETEST LINEZOLID | LTX | 2000-11-08 | 114 |
| K001547 | ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP | JWY | 2000-08-07 | 81 |
54 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ab Biodisk.
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 Ab Biodisk?
FDA lists 64 510(k) clearances under the applicant name “Ab Biodisk” (first 1991, latest 2008), across 3 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 Ab Biodisk?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ab Biodisk is 78 days.
Which FDA product codes appear under Ab Biodisk?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 61); LTX (Discs, Elution, 2); NGZ (Susceptibility Test Plate, Antifungal, 1).
Next steps
- See all 64 Ab Biodisk clearances with predicates and recalls
- Run predicate analysis for product code JWY, Ab Biodisk'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.