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JBQ — Predicate Candidate Screening

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

65 daysmedian FDA review time

220 days90th percentile

56clearances measured

K-number	Device	Applicant	Decided	Review days
K242952	INNOVANCE Antithrombin	Siemens Healthcare Diagnostic Products GmbH	2025-03-28	184
K081769	INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5	Siemens Healthcare Diagnostics	2009-05-28	339
K070301	HEMOSIL ANTITHROMBIN	Instrumentation Laboratory CO	2007-02-23	23
K062431	HEMOSIL LIQUID ANTITHROMBIN	Instrumentation Laboratory CO	2006-09-01	11
K043007	BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITH	Hyphen Biomed	2005-11-07	371
K033775	HEMOSIL LIQUID ANTITHROMBIN XL	Instrumentation Laboratory CO	2004-01-02	30
K023991	CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50	Precision Biologic	2003-04-28	146
K022550	COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS	Instrumentation Laboratory CO	2002-08-27	25
K022195	COAMATIC AT-400	Instrumentation Laboratory CO	2002-08-07	33
K994238	IL TEST LIQUID ANTITHROMBIN	Instrumentation Laboratory CO	2000-06-23	190
K000361	K-ASSAY AT-III	Kamiya Biomedical Co.	2000-04-26	82
K980499	IL TEST ANTITHROMBIN	Instrumentation Laboratory CO	1998-04-02	52
K974110	IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT	Beckman Instruments, Inc.	1997-12-24	54
K972144	SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III	Sigma Diagnostics, Inc.	1997-07-25	49
K960871	SPECTROLYSE ANTITHROMBIN III (ANTI-XA)	Medical Diagnostic Technologies, Inc.	1996-08-14	163
K952515	COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY	Chromogenix AB	1996-01-23	237
K951943	CHROM Z CHROMOGENIC ASSAYS	Helena Laboratories	1995-11-13	201
K944279	AT-III CALIBRATOR	American Bioproducts Co.	1995-04-07	220
K934156	BIOMERIEUX HEMOLAB AT III	Biomerieux Vitek, Inc.	1994-12-22	482
K935308	ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY	Sigma Diagnostics, Inc.	1994-05-17	196
K936196	ANTITHROMBIN III CHROMOGENIC ASSAY	Baxter Diagnostics, Inc.	1994-05-04	126
K931420	COATEST(R) ANTITHROMBIN III, MODIFICATION	Kabi Pharmacia Hepar, Inc.	1994-05-02	419
K915083	COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY	Kabi Pharmacia, Inc.	1992-01-03	52
K913667	ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT	The Binding Site, Ltd.	1992-01-03	137
K905110	LIATEST(R) AT III TEST KIT	American Bioproducts Co.	1991-01-24	72
K902393	COACUTE ANTITHROMBIN CHROMOGENIC ASSAY	Kabi Diagnostica	1990-09-25	118
K902530	SPECTROLYSE ATIII KIT	Biopool AB	1990-08-09	65
K901977	BECKMAN ANTITHROMBIN III REAGENT KIT	Beckman Instruments, Inc.	1990-08-06	96
K900400	ORTHOKROME* ANTITHROMBIN	Ortho Diagnostic Systems, Inc.	1990-03-15	45
K893608	ACTICHROME ATIII KIT	American Diagnostic Corp.	1989-06-23	44
K884144	TURBOX ANTITHROMBIN III	Unipath , Ltd.	1988-12-20	81
K883662	BERICHROM(R) ANTITHROMBIN III	Behring Diagnostics, Inc.	1988-11-23	89
K880700	ENZYGNOST(R) TAT REAGENTS	Behring Diagnostics, Inc.	1988-04-27	65
K880315	DADE ANTITHROMBIN III CHROMOGENIC ASSAY	Baxter Healthcare Corp	1988-03-16	50
K864214	IL TEST 97574-15M, ANTITTHROMBIN III ASSASY	Instrumentation Laboratory CO	1986-11-25	28
K850412	GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY	Warner-Lambert Co.	1985-05-08	93
K841736	IL TEST ANTITHROMBIN III ACTIVITY	Instrumentation Laboratory CO	1984-09-06	132
K832592	DIACROM * ATIII	Wellcome Diagnostics	1983-09-29	58
K832268	RABBIT ANTI-HUMAN ANTITHROMBIN III	Gelco Diagnostics, Inc.	1983-08-12	43
K831961	IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN	Kent Laboratories, Inc.	1983-08-11	55
K831297	PROTOTRO/PROTEOLYTIC ENZYME CONTROL	American Dade	1983-06-08	48
K812829	COATEST ANTITHROMBIN	Kabivitrum, Inc.	1981-12-30	83
K812626	ACA ANTITHROMBIN III PLASMINOGEN CALIB	E.I. Dupont DE Nemours & Co., Inc.	1981-11-24	70
K812627	ACA ANTITHROMBIN III TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1981-10-08	23
K812215	ANTITHROMBIN III SCREEN KIT	Pacific Hemostasis	1981-09-01	27
K802912	HELENA AT-III QUIPLATE PROCEDURE	Helena Laboratories	1980-12-22	34
K792019	PHADECODE XA INHIBITOR ASSAY	Pharmaseal Div., Baxter Healthcare Corp.	1979-11-05	27
K790090	DETERMINATION OF ANTITHROMBIN III, 885	Sigma Chemical Co.	1979-02-26	41
K781860	ASSAY, CHROMOGENIC ANTITHROMBIN III	Ortho Diagnostics, Inc.	1978-12-04	28
K781480	ANTITHROMBIN III ASSAY	Dade, Baxter Travenol Diagnostics, Inc.	1978-11-08	72

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