Idt, A Division of Whittaker M.A. Bioproducts: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Idt, A Division of Whittaker M.A. Bioproducts” (first 1977, latest 1986), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 1 | 1 |
| GQX | Antiserum, Cf, Varicella-Zoster | 1 | 1 |
| GRE | Antiserum, Fluorescent, Rubeola | 1 | 1 |
Review panels
- Immunology (3)
- Microbiology (2)
Most recent Idt, A Division of Whittaker M.A. Bioproducts 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853540 | FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY | GQX | 1986-02-04 | 165 |
| K853067 | FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT | GRE | 1985-10-22 | 92 |
| K782041 | FIAX TEST KIT | DHN | 1979-01-03 | 27 |
| K772219 | FIAX TEST FOR ANTI-RUBELLA ANTIBODY | DHN | 1978-01-20 | 46 |
| K772114 | FIAX C4 ASSAY | DAK | 1977-11-30 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Idt, A Division of Whittaker M.A. Bioproducts.
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 Idt, A Division of Whittaker M.A. Bioproducts?
FDA lists 5 510(k) clearances under the applicant name “Idt, A Division of Whittaker M.A. Bioproducts” (first 1977, latest 1986), across 4 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 Idt, A Division of Whittaker M.A. Bioproducts?
The median time from FDA receipt to decision across 510(k)s cleared under the name Idt, A Division of Whittaker M.A. Bioproducts is 46 days.
Which FDA product codes appear under Idt, A Division of Whittaker M.A. Bioproducts?
The most frequent FDA product codes under this applicant name are DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); DAK (Complement C1q, Antigen, Antiserum, Control, 1); GQX (Antiserum, Cf, Varicella-Zoster, 1).
Next steps
- See all 5 Idt, A Division of Whittaker M.A. Bioproducts clearances with predicates and recalls
- Run predicate analysis for product code DHN, Idt, A Division of Whittaker M.A. Bioproducts'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.