Biowhittaker Molecular Applications, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biowhittaker Molecular Applications, Inc.” (first 1992, latest 1996), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 236 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 3 | 3 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 1 | 1 |
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
Review panels
- Immunology (4)
- Clinical Chemistry (3)
- Microbiology (3)
Most recent Biowhittaker Molecular Applications, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943843 | VARICELISA, MODIFICATION | LFY | 1996-03-14 | 595 |
| K942361 | WHITSOFT | JJQ | 1995-04-04 | 322 |
| K942250 | BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER | JJQ | 1995-04-04 | 330 |
| K942245 | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE | JJQ | 1995-04-03 | 329 |
| K925209 | MUMPS STAT | LJY | 1994-10-14 | 737 |
| K935618 | SPECIMEN TRANSPORT MEDIUM | JSM | 1994-04-21 | 150 |
| K932679 | RHEUMELISA II HISTONE ANTIBODY TEST KIT | LKJ | 1993-08-23 | 82 |
| K930757 | RHEUMELISA II JO-1 ANTIBODY TEST KIT | LLL | 1993-03-26 | 42 |
| K930130 | RHEUMELISA II SCL-70 ANTIBODY TEST KIT | LLL | 1993-03-23 | 70 |
| K920753 | RF STAT IGM TEST KIT | DHR | 1992-03-30 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Biowhittaker Molecular Applications, 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 Biowhittaker Molecular Applications, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Biowhittaker Molecular Applications, Inc.” (first 1992, latest 1996), across 7 product codes in 3 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 Biowhittaker Molecular Applications, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biowhittaker Molecular Applications, Inc. is 236 days.
Which FDA product codes appear under Biowhittaker Molecular Applications, Inc.?
The most frequent FDA product codes under this applicant name are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 3); LLL (Extractable Antinuclear Antibody, Antigen And Control, 2); DHR (System, Test, Rheumatoid Factor, 1).
Next steps
- See all 10 Biowhittaker Molecular Applications, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Biowhittaker Molecular Applications, 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.