Biokit USA, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Biokit USA, Inc.” (first 1984, latest 1993), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 4 | 4 |
| DHR | System, Test, Rheumatoid Factor | 3 | 3 |
| DCN | System, Test, C-Reactive Protein | 2 | 2 |
| LQN | Latex Agglutination Assay, Rubella | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| GMP | Antisera, Control For Nontreponemal Tests | 1 | 1 |
| GMQ | Antigens, Nontreponemal, All | 1 | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
| LLA | Direct Agglutination Test, Toxoplasma Gondii | 1 | 1 |
Review panels
- Microbiology (10)
- Immunology (6)
Most recent Biokit USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913467 | TOXOGEN | LLA | 1993-01-11 | 525 |
| K910541 | BIOKIT RPR | GMQ | 1991-10-18 | 256 |
| K904310 | RHEUMAGEN RF T-CONTROL | DHR | 1991-05-31 | 254 |
| K910539 | RHEUMAJET RF | DHR | 1991-04-05 | 67 |
| K910686 | RHEUMAJET CRP | DCN | 1991-03-19 | 28 |
| K904311 | RHEUMAGEN ASO T-CONTROL | GTQ | 1991-01-25 | 128 |
| K904312 | RHEUMAGEN CRP T-CONTROL | DCK | 1990-10-01 | 12 |
| K896433 | MODIFIED RUBAGEN | LQN | 1989-11-29 | 20 |
| K896272 | QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL | DCN | 1989-11-08 | 9 |
| K896271 | QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) | DHR | 1989-11-08 | 9 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biokit USA, 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.
- Biokit, S.A. (23 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biokit USA, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Biokit USA, Inc.” (first 1984, latest 1993), across 9 product codes in 2 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 Biokit USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biokit USA, Inc. is 49 days.
Which FDA product codes appear under Biokit USA, Inc.?
The most frequent FDA product codes under this applicant name are GTQ (Antistreptolysin - Titer/Streptolysin O Reagent, 4); DHR (System, Test, Rheumatoid Factor, 3); DCN (System, Test, C-Reactive Protein, 2).
Next steps
- See all 16 Biokit USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GTQ, Biokit USA, 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.