Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bio-Chem Laboratory Systems, Inc. · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

184 daysmedian FDA review time
273 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945271ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEMBio-Chem Laboratory Systems, Inc.1995-04-201840
K930689AUTOBEAD THYROID UPTAKEBio-Chem Laboratory Systems, Inc.1993-11-102730
K930006AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KITBio-Chem Laboratory Systems, Inc.1993-09-092480
K926563AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KITBio-Chem Laboratory Systems, Inc.1993-03-18770
K924084ATAC 6000 CHEMISTRY ANALYZERBio-Chem Laboratory Systems, Inc.1992-09-29470

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