Amf Biological and Diagnostics Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Amf Biological and Diagnostics Co.” (first 1981, latest 1985), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
| KIS | Sera, Animal And Human | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Pathology (1)
Most recent Amf Biological and Diagnostics Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852418 | QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) | JJY | 1985-07-15 | 38 |
| K821931 | ZETA-CORT | CGR | 1982-07-22 | 23 |
| K821554 | ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT | CDX | 1982-06-25 | 31 |
| K821553 | ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT | KHQ | 1982-06-25 | 31 |
| K812329 | ZETA-SERA D | KIS | 1981-09-01 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Amf Biological and Diagnostics Co..
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 Amf Biological and Diagnostics Co.?
FDA lists 5 510(k) clearances under the applicant name “Amf Biological and Diagnostics Co.” (first 1981, latest 1985), across 5 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 Amf Biological and Diagnostics Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amf Biological and Diagnostics Co. is 31 days.
Which FDA product codes appear under Amf Biological and Diagnostics Co.?
The most frequent FDA product codes under this applicant name are CDX (Radioimmunoassay, Total Thyroxine, 1); CGR (Radioimmunoassay, Cortisol, 1); JJY (Multi-Analyte Controls, All Kinds (Assayed), 1).
Next steps
- See all 5 Amf Biological and Diagnostics Co. clearances with predicates and recalls
- Run predicate analysis for product code CDX, Amf Biological and Diagnostics Co.'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.