Lab Ability, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Lab Ability, Inc.” (first 1981, latest 1983), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 27 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 | 2 | 2 |
| JTR | Kit, Quality Control For Culture Media | 1 | 1 |
| LIA | Antigens, All Groups, Shigella Spp. | 1 | 1 |
| LJG | Quality Control Slides | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Lab Ability, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833407 | SELECTO-DISC NOVOBIOCIN 5UG | JTO | 1983-12-30 | 91 |
| K832436 | SELECTRO-DISC | JTO | 1983-09-26 | 63 |
| K830133 | Q-CHECK CULTI-LOOPS | JTR | 1983-02-09 | 27 |
| K830134 | Q-CHECK REAGENT STANDARDS | LJG | 1983-01-09 | 0 |
| K813191 | SHIGELLA SERA-CHEK | LIA | 1981-12-03 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Lab Ability, 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 Lab Ability, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Lab Ability, Inc.” (first 1981, latest 1983), across 4 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 Lab Ability, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lab Ability, Inc. is 27 days.
Which FDA product codes appear under Lab Ability, Inc.?
The most frequent FDA product codes under this applicant name are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 2); JTR (Kit, Quality Control For Culture Media, 1); LIA (Antigens, All Groups, Shigella Spp., 1).
Next steps
- See all 5 Lab Ability, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTO, Lab Ability, 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.