Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biochem Immunosystems (U.S.), 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) |
|---|---|---|---|---|---|
| K971761 | PERSONALLAB AUTOMATED MICROPLATE ANALYZER | Biochem Immunosystems (U.S.), Inc. | 1997-07-22 | 71 | 0 |
| K960072 | SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX | Biochem Immunosystems (U.S.), Inc. | 1997-03-06 | 426 | 0 |
| K954065 | BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT | Biochem Immunosystems (U.S.), Inc. | 1996-07-10 | 315 | 0 |
| K955102 | BIODATA TESTOSTERONE MAIA KIT | Biochem Immunosystems (U.S.), Inc. | 1996-06-24 | 229 | 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