Whittaker Bioproducts, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Whittaker Bioproducts, Inc.” (first 1984, latest 1992), across 20 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | 4 | 4 |
| LSR | Reagent, Borrelia Serological Reagent | 4 | 4 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 2 | 2 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 2 | 2 |
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | 2 | 2 |
| LYR | Helicobacter Pylori | 2 | 2 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 1 | 1 |
| GNY | Antisera, Fluorescent, Adenovirus 1-33 | 1 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
Plus 10 more product codes.
Review panels
- Microbiology (26)
- Immunology (4)
Most recent Whittaker Bioproducts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911356 | LEGIONELLA STAT IGG/IGM TEST KIT | MJH | 1992-07-30 | 490 |
| K913212 | 3M IGE SINGLE POINT FAST TEST | DHB | 1991-11-22 | 126 |
| K904652 | LYME STAT M TEST KIT | LSR | 1991-10-21 | 371 |
| K904893 | FIAX LYME M TEST KIT | LSR | 1991-10-16 | 351 |
| K911473 | EBNA STAT TEST KIT | LLM | 1991-09-25 | 174 |
| K905468 | PYLORI-G FIAX TEST KIT | LYR | 1991-05-07 | 152 |
| K904738 | PYLORI STAT TEST KIT | LYR | 1991-05-07 | 201 |
| K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B | GNX | 1990-06-27 | 90 |
| K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A | GNX | 1990-01-16 | 252 |
| K894932 | FIAX EB VCA-M TEST KIT | LSE | 1989-10-16 | 74 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Whittaker Bioproducts, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Whittaker Bioproducts, Inc. (a text match, not an official crosswalk):
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.
- Whittaker General Medical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Whittaker Bioproducts, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Whittaker Bioproducts, Inc.” (first 1984, latest 1992), across 20 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 Whittaker Bioproducts, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Whittaker Bioproducts, Inc. is 84 days.
Which FDA product codes appear under Whittaker Bioproducts, Inc.?
The most frequent FDA product codes under this applicant name are LSE (Epstein-Barr Virus, Other, 4); LSR (Reagent, Borrelia Serological Reagent, 4); GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C, 2).
Next steps
- See all 30 Whittaker Bioproducts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSE, Whittaker Bioproducts, 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.