Pro-Lab, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Pro-Lab, Inc.” (first 1984, latest 1995), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 59 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 |
|---|---|---|---|
| JSK | Supplement, Culture Media | 7 | 7 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 3 | 3 |
| FRG | Wrap, Sterilization | 2 | 2 |
| JSE | Culture Media, Multiple Biochemical Test | 2 | 2 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| GNA | Antisera, All Types, Escherichia Coli | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 1 |
| JTR | Kit, Quality Control For Culture Media | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Pro-Lab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934383 | PROLEX (STREPTOCCAL GROUPING LATEX KIT) | GTZ | 1995-01-27 | 505 |
| K914419 | AMNIOTEST(TM) | HIO | 1993-09-01 | 699 |
| K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | LHL | 1992-07-28 | 126 |
| K903714 | E. COLI 0157 LATEX TEST | GNA | 1991-01-24 | 163 |
| K894221 | ROSCO PYRR | JTO | 1989-09-28 | 101 |
| K883996 | X-ACT LDC/IND | JSE | 1988-10-12 | 22 |
| K883995 | X-ACT UREA/TDA | JSE | 1988-10-12 | 22 |
| K871121 | PROTECT T.M. | JTR | 1987-04-14 | 26 |
| K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | JSX | 1987-03-20 | 67 |
| K861142 | MASTER KIT B | LRP | 1986-07-10 | 106 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pro-Lab, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pro-Lab Diagnostics (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pro-Lab, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Pro-Lab, Inc.” (first 1984, latest 1995), across 13 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pro-Lab, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pro-Lab, Inc. is 59 days.
Which FDA product codes appear under Pro-Lab, Inc.?
The most frequent FDA product codes under this applicant name are JSK (Supplement, Culture Media, 7); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 3); FRG (Wrap, Sterilization, 2).
Next steps
- See all 27 Pro-Lab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSK, Pro-Lab, 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.