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

GGC — Predicate Candidate Screening

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

55 daysmedian FDA review time

336 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days
K102552	HEMOSIL LA POSITIVE CONTROL	Instrumentation Laboratory CO	2011-04-05	210
K100103	SPECIALTY ASSAYED CONTROL-2	Helena Laboratories	2010-12-15	336
K062306	PLASMACON N, PLASMACON L-1, PLASMACON L-2	R2 Diagnostics, Inc.	2007-03-16	220
K061803	STA - CONTROL LA 1+2	Diagnostica Stago, Inc.	2006-07-28	31
K032804	CRYOCHECK WEAK LUPUS POSITIVE CONTROL	Precision Biologic	2003-11-03	55
K023312	CONTROL PLASMA P	Dade Behring, Inc.	2002-11-01	29
K020878	LYPHOCHEK HEMOSTASIS, MODELS 798, 799	Bio-Rad	2002-04-15	28
K020109	SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL	Sigma Diagnostics, Inc.	2002-02-06	26
K012422	K-ASSAY D-DIMER CONTROLS	Kamiya Biomedical Co.	2001-08-21	22
K003329	SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217	Sigma Diagnostics, Inc.	2001-03-01	128
K993332	GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-	Gradipore , Ltd.	2000-02-16	135
K984130	COAGULATION CONTROL LEVEL 2 (ABNORMAL)	Pacific Hemostasis	1998-12-01	13
K984131	COAGULATION CONTROL LEVEL 3 (ABNORMAL)	Pacific Hemostasis	1998-12-01	13
K961370	LA POSITIVE CONTROL PLASMA	Medical Diagnostic Technologies, Inc.	1996-05-24	45
K955040	AT-III CONTROL PLASMA KIT	American Bioproducts Co.	1996-01-31	89
K952623	CRYO CHECK LUPUS PLASMA	Precision Biologicals, Inc.	1995-11-06	151
K952624	CRYO CHECK ABNORMAL REFERENCE CHECK I & II	Precision Biologicals, Inc.	1995-10-30	144
K945856	POSITIVE LUPUS ANTICOAGULANT PLASMA	George King Bio-Medical, Inc.	1995-10-05	325
K952338	STA-COAG CONTROL [P] PLUS KIT	American Bioproducts Co.	1995-09-21	125
K941872	SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302	Helena Laboratories	1994-11-21	217
K930267	BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL	Biomerieux Vitek, Inc.	1994-03-22	427
K924402	CONTROL PLASMA U	Behring Diagnostics, Inc.	1994-02-22	540
K924401	PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)	Behring Diagnostics, Inc.	1994-02-22	540
K930959	FACTOR CONTROL [P]	American Bioproducts Co.	1993-05-20	85
K930923	COAG-CONTROL	American Bioproducts Co.	1993-04-27	63
K924405	CONTROL PLASMA P	Behring Diagnostics, Inc.	1992-12-01	92
K921665	AVK CONTROL I & II	American Bioproducts Co.	1992-06-09	63
K911885	DADE(R) PROTEIN C ABNORMAL CONTRAL	Baxter Healthcare Corp	1991-06-11	43
K904073	COAGULATION REFERENCE PLASMA, ABNORMAL	Medi-Tech, Inc.	1990-10-22	47
K901233	ORTHO ABNORMAL PROTEIN C CONTROL PLASMA	Ortho Diagnostic Systems, Inc.	1990-04-11	28
K900782	HEPARIN CONTROL PLASMA, FOR USE IN APTT	Medical Diagnostic Technologies, Inc.	1990-03-27	35
K895261	ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)	Medical Diagnostic Technologies, Inc.	1989-10-06	45
K895260	ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)	Medical Diagnostic Technologies, Inc.	1989-10-06	45
K894425	ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III	Analytical Control Systems, Inc.	1989-08-03	17
K894338	ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III	Analytical Control Systems, Inc.	1989-07-25	11
K893970	ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II	Analytical Control Systems, Inc.	1989-07-25	53
K893971	ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II	Analytical Control Systems, Inc.	1989-07-25	53
K881510	CLP ABNORMAL COAGULATION CONTROL	Creative Laboratory Products, Inc.	1988-05-06	25
K871420	HERPES 1 AND 2 MICROASSAYS	Diamedix Corp.	1987-12-11	247
K770188	HPC TM (HEPARINIZED PLASMA CONTROL)	Bio/Data Corp.	1977-02-18	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