Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Bioclinical, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852939 | CORTISOL SYSTEM BY EIA | American Bioclinical, Inc. | 1985-08-02 | 23 | 0 |
| K852437 | VISUAL SERUM/URINE HCG COMBO KIT | American Bioclinical, Inc. | 1985-07-12 | 32 | 0 |
| K852376 | SIMULTANEOUS LH/FSH SYSTEM BY RIA | American Bioclinical, Inc. | 1985-07-09 | 35 | 0 |
| K851330 | PROLACTIN SYSTEM BY RIA | American Bioclinical, Inc. | 1985-04-29 | 25 | 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