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

GGN — Predicate Candidate Screening

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

75 daysmedian FDA review time

298 days90th percentile

99clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K170864	VALIDATE D-Dimer Calibration Verification / Linearity Test K	Maine Standards Company, LLC	2017-06-21	90	0
K163498	VALIDATE Heparin Calibration Verification/Linearity Test Kit	Maine Standards Company, LLC	2017-03-16	93	0
K161316	George King Coumadin Plasma	George King Bio-Medical, Inc.	2017-02-23	288	0
K162705	VALIDATE® D-Dimer Calibration Verification/ Linearity Test K	Maine Standards Company, LLC	2017-01-05	99	0
K152961	VALIDATE D-Dimer Calibration Verification/Linearity Test Kit	Maine Standards Company, LLC	2016-06-03	240	0
K150144	VisuCon-F Low Fibrinogen Control Plasma	Affinity Biologicals, Inc.	2016-03-06	409	0
K142132	POOL NORM	Diagnostics Stago S.A.S.	2014-12-12	130	0
K133582	HEMOSIL D-DIMER HS 500 CONTROL	Instrumentation Laboratory	2014-08-15	267	0
K120977	DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTE	International Technidyne Corp.	2013-07-03	457	0
K120900	I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2	Cliniqa Corporation	2013-05-31	431	0
K120014	STA- COAG CONTROL (N+ABN) PLUS	Diagnostica Stago, Inc.	2013-03-14	441	0
K113211	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	Instrumentation Laboratory CO	2012-01-04	65	0
K110432	VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN	Affinity Biologicals, Inc.	2011-10-20	247	0
K100716	AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5	Aalto Scientific, Ltd.	2011-06-23	468	0
K093848	PT-MULTI-CALIBRATOR, MODEL OPAT07	Dade Behring, Inc.	2010-12-20	369	0
K103314	CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL	Medtronic, Inc.	2010-12-03	23	0
K103313	HEPARIN ASSAY CONTROLS	Medtronic, Inc.	2010-12-01	21	0
K091284	VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORM	Affinity Biologicals, Inc.	2009-10-28	180	0
K090563	HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWAR	Instrumentation Laboratory CO	2009-10-09	221	0
K082859	HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED	Instrumentation Laboratory CO	2008-12-19	81	0
K071319	I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND	Bio-Rad, Diagnostics Grp.	2007-06-26	47	0
K062840	TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTR	Biosite Incorporated	2007-03-01	160	0
K063823	COAGUCHEK XS PT CONTROLS	Roche Diagnostics Corp.	2007-01-29	34	0
K052697	HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL	Akers Biosciences, Inc.	2006-01-04	98	0
K051472	BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN	Hyphen Biomed	2005-12-23	203	0
K050799	TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(	Biosite Incorporated	2005-06-29	91	0
K043451	BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA C	Hyphen Biomed	2005-03-17	93	0
K042760	PEFAKIT APC-R FACTOR V LEIDEN CONTROLS	Pentapharm , Ltd.	2004-12-22	78	0
K042333	CONTROL PLASMA N, PROC CONTROL PLASMA	Dade Behring, Inc.	2004-12-01	93	0
K042209	CONTROL PLASMA N AND CONTROL PLASMA P	Dade Behring, Inc.	2004-10-21	66	0
K042206	PURPLE/BLACK HEPARIN ASSAY CONTROL	Medtronic Vascular	2004-10-18	63	0
K042175	HEPARINASE HR ACT CONTROL, MODEL 550-12	Medtronic Vascular	2004-10-18	68	0
K040275	LYPHOCHEK HEMOSTASIS CONTROL	Bio-Rad	2004-02-27	22	0
K032611	LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743	Bio-Rad	2003-09-17	23	0
K032017	LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3	Bio-Rad	2003-08-08	39	0
K030965	CONTROL PLASMA LMW HEPARIN	Instrumentation Laboratory CO	2003-06-06	71	0
K030182	LIQUICHEK D-DIMER CONTROL, MODEL 356, 357	Bio-Rad	2003-02-24	38	0
K022046	VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEV	Vital Scientific N.V.	2002-07-23	29	0
K021024	HEMOSIL HIGH ABNORMAL CONTROL ASSAYED	Instrumentation Laboratory CO	2002-05-16	48	3
K021023	HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (	Instrumentation Laboratory CO	2002-05-14	46	3
K021022	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNOR	Instrumentation Laboratory CO	2002-05-14	46	3
K012722	LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION	Bio-Rad	2001-09-18	34	0
K010750	PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560	Fisher Diagnostics	2001-09-07	178	0
K010350	STA -CALIBRATOR HBPM/LMWH KIT	Diagnostica Stago, Inc.	2001-04-09	63	0
K010324	STA-QUALITY HBPM/LMWH KIT	Diagnostica Stago, Inc.	2001-04-09	66	0
K000679	THROMBOSTRATE CONTROL PLASMAS	Pacific Hemostasis	2000-03-24	24	0
K994159	HMP CONTROLS (TAS) RAPIDPOINT	Cardiovascular Diagnostics, Inc.	2000-02-15	68	0
K991439	POLLER CALIBRANTS	European Concerted Action on Anticoagulation	1999-12-20	238	0
K992829	CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3	Medical Analysis Systems, Inc.	1999-11-22	91	0
K992279	HEPARIN CONTROL PLASMA LEVEL 2	Pacific Hemostasis	1999-08-26	50	0

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