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

DAD — Predicate Candidate Screening

18 FDA 510(k) clearances under this product code; the 50 most recent screened below.

38 daysmedian FDA review time

212 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K993480	K-ASSAY HAPTOGLOBIN	Kamiya Biomedical Co.	1999-11-24	41
K972639	TINA-QUANT HAPTOGLOBIN	Boehringer Mannheim Corp.	1998-01-09	178
K964301	N-ASSAY TIA MULTI V-NL	Crestat Diagnostics, Inc.	1997-07-14	258
K963286	IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT	Beckman Instruments, Inc.	1996-10-07	47
K952593	N/T PROTEIN CONTROL SY/L, M AND H	Behring Diagnostics, Inc.	1995-07-17	41
K915829	IL TEST(TM) HAPTOGLOBIN (HPT)	Instrumentation Laboratory CO	1992-07-29	212
K911898	RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT	Reagents Applications, Inc.	1991-05-08	12
K890562	SPQ(TM) ANTIBODY REAGENT SET II FOR HPT	Atlantic Antibodies	1989-02-22	29
K873866	HAPTOGLOBIN	Unipath , Ltd.	1987-10-20	57
K872717	QM300 HAPTOGLOBIN ANTIBODY PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1987-07-21	11
K864512	IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO	Cooper Biomedical, Inc.	1987-02-13	92
K850584	SPQ TEST SYSTEM FOR HAPTOGLOBIN	Applications Lab	1985-03-05	20
K840404	DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO	Tago, Inc.	1984-03-09	38
K831957	DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB	Kent Laboratories, Inc.	1983-07-18	31
K812494	IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO	Dako Corp.	1981-09-23	23
K801433	HAPTOGLOBIN NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-07-08	20
K772245	HAPTOGLOBIN NEPHELOMETRIC ASSAY	Kallestad Laboratories, Inc.	1977-12-22	13
K760144	SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID	Oxford Laboratories, Inc.	1976-07-20	21

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