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

GIS — Predicate Candidate Screening

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

82 daysmedian FDA review time

197 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K143470	Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set,	Diazyme Laboratories	2016-01-31	422
K042919	FIBROTEK FIB	R2 Diagnostics, Inc.	2004-11-29	38
K993482	K-ASSAY FIBRINOGEN	Kamiya Biomedical Co.	1999-12-06	53
K963902	QUANTITATIVE FIBRINOGEN ASSAY	Ortho Diagnostic Systems, Inc.	1996-11-29	63
K941001	ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT	Diagnostic Specialties	1994-08-30	182
K925494	BIOMERIEUX HEMOLAB FIBRINOMAT	Biomerieux Vitek, Inc.	1993-05-18	197
K923921	IL TEST PT FIBRINOGEN HS	Instrumentation Laboratory CO	1992-10-26	82
K913061	FIBRINOGEN DETERMINATION KIT	Sigma Diagnostics, Inc.	1991-10-09	91
K910636	ABS CADKIT	Panbio, Inc.	1991-04-29	75
K903874	FIBRINOTEST(TM) - FIBRINOGEN ASSAY	Haemachem, Inc.	1991-02-14	176
K881685	FIBRINOGENTEST-O	Diatech, Inc.	1988-08-09	112
K881150	KINETIC FIBRINOGEN ASSAY	Bio/Data Corp.	1988-03-28	11
K781880	ASSAY KIT, THROMBO-SCREEN	Pacific Hemostasis	1978-12-04	28

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