Atlas FDA

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

Advanced Biological Products, Inc. — Predicate Candidate Screening

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

231 daysmedian FDA review time
231 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K924952ELISA-DOXA COMBI-6Advanced Biological Products, Inc.1993-05-192310
K924946ELISA-DOXA SSBAdvanced Biological Products, Inc.1993-05-192310
K924948ELISA-DOXA SM/RNPAdvanced Biological Products, Inc.1993-05-192310
K924951ELISA-DOXA COMBI-4Advanced Biological Products, Inc.1993-05-192310
K924947ELISA-DOXA SMAdvanced Biological Products, Inc.1993-05-192310
K924945ELISA-DPXA SSA KITAdvanced Biological Products, Inc.1993-05-192310
K924949ELISA-DOXA SCL-70Advanced Biological Products, Inc.1993-05-192310
K924950ELISA-DOXA JO-1Advanced Biological Products, Inc.1993-05-192310

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