Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amf Biological and Diagnostics Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
38 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852418 | QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) | Amf Biological and Diagnostics Co. | 1985-07-15 | 38 | 0 |
| K821931 | ZETA-CORT | Amf Biological and Diagnostics Co. | 1982-07-22 | 23 | 0 |
| K821553 | ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT | Amf Biological and Diagnostics Co. | 1982-06-25 | 31 | 0 |
| K821554 | ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT | Amf Biological and Diagnostics Co. | 1982-06-25 | 31 | 0 |
| K812329 | ZETA-SERA D | Amf Biological and Diagnostics Co. | 1981-09-01 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda