FDA 510(k) Applications for Medical Device Product Code "JBQ"
(Antithrombin Iii Quantitation)

FDA 510(k) Number Applicant Device Name Decision Date
K771669 ABBOTT LABORATORIES DIAG. KIT FOR TOTAL ANTITHROMBIN III 11/09/1977
K944279 AMERICAN BIOPRODUCTS CO. AT-III CALIBRATOR 04/07/1995
K905110 AMERICAN BIOPRODUCTS CO. LIATEST(R) AT III TEST KIT 01/24/1991
K831297 AMERICAN DADE PROTOTRO/PROTEOLYTIC ENZYME CONTROL 06/08/1983
K893608 AMERICAN DIAGNOSTIC CORP. ACTICHROME ATIII KIT 06/23/1989
K936196 BAXTER DIAGNOSTICS, INC. ANTITHROMBIN III CHROMOGENIC ASSAY 05/04/1994
K880315 BAXTER HEALTHCARE CORP. DADE ANTITHROMBIN III CHROMOGENIC ASSAY 03/16/1988
K770394 BAY AREA HEMA. ONCO. CLINIC. & RES. L THROMBO-SCREEN AT-111 KIT 03/30/1977
K901977 BECKMAN INSTRUMENTS, INC. BECKMAN ANTITHROMBIN III REAGENT KIT 08/06/1990
K974110 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT 12/24/1997
K883662 BEHRING DIAGNOSTICS, INC. BERICHROM(R) ANTITHROMBIN III 11/23/1988
K880700 BEHRING DIAGNOSTICS, INC. ENZYGNOST(R) TAT REAGENTS 04/27/1988
K934156 BIOMERIEUX VITEK, INC. BIOMERIEUX HEMOLAB AT III 12/22/1994
K902530 BIOPOOL AB SPECTROLYSE ATIII KIT 08/09/1990
K952515 CHROMOGENIX AB COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY 01/23/1996
K781480 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. ANTITHROMBIN III ASSAY 11/08/1978
K812626 E.I. DUPONT DE NEMOURS & CO., INC. ACA ANTITHROMBIN III PLASMINOGEN CALIB 11/24/1981
K812627 E.I. DUPONT DE NEMOURS & CO., INC. ACA ANTITHROMBIN III TEST PACK 10/08/1981
K832268 GELCO DIAGNOSTICS, INC. RABBIT ANTI-HUMAN ANTITHROMBIN III 08/12/1983
K951943 HELENA LABORATORIES CHROM Z CHROMOGENIC ASSAYS 11/13/1995
K802912 HELENA LABORATORIES HELENA AT-III QUIPLATE PROCEDURE 12/22/1980
K772328 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R HUMAN ANTITHROMBIN III TEST 02/03/1978
K043007 HYPHEN BIOMED BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 11/07/2005
K781026 ICL SCIENTIFIC ANTITHROMBIN III SERUM, ANTI-HUMAN 08/10/1978
K022195 INSTRUMENTATION LABORATORY CO. COAMATIC AT-400 08/07/2002
K022550 INSTRUMENTATION LABORATORY CO. COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS 08/27/2002
K070301 INSTRUMENTATION LABORATORY CO. HEMOSIL ANTITHROMBIN 02/23/2007
K062431 INSTRUMENTATION LABORATORY CO. HEMOSIL LIQUID ANTITHROMBIN 09/01/2006
K033775 INSTRUMENTATION LABORATORY CO. HEMOSIL LIQUID ANTITHROMBIN XL 01/02/2004
K864214 INSTRUMENTATION LABORATORY CO. IL TEST 97574-15M, ANTITTHROMBIN III ASSASY 11/25/1986
K980499 INSTRUMENTATION LABORATORY CO. IL TEST ANTITHROMBIN 04/02/1998
K841736 INSTRUMENTATION LABORATORY CO. IL TEST ANTITHROMBIN III ACTIVITY 09/06/1984
K994238 INSTRUMENTATION LABORATORY CO. IL TEST LIQUID ANTITHROMBIN 06/23/2000
K902393 KABI DIAGNOSTICA "COACUTE ANTITHROMBIN" CHROMOGENIC ASSAY 09/25/1990
K931420 KABI PHARMACIA HEPAR, INC. COATEST(R) ANTITHROMBIN III, MODIFICATION 05/02/1994
K915083 KABI PHARMACIA, INC. COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY 01/03/1992
K812829 KABIVITRUM, INC. COATEST ANTITHROMBIN 12/30/1981
K000361 KAMIYA BIOMEDICAL CO. K-ASSAY AT-III 04/26/2000
K831961 KENT LABORATORIES, INC. IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN 08/11/1983
K960871 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. SPECTROLYSE ANTITHROMBIN III (ANTI-XA) 08/14/1996
K900400 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHOKROME* ANTITHROMBIN 03/15/1990
K780002 ORTHO DIAGNOSTICS, INC. ANTITHROMBIN III ASSAY 01/31/1978
K781860 ORTHO DIAGNOSTICS, INC. ASSAY, CHROMOGENIC ANTITHROMBIN III 12/04/1978
K812215 PACIFIC HEMOSTASIS ANTITHROMBIN III SCREEN KIT 09/01/1981
K770942 PHARMASEAL DIV., BAXTER HEALTHCARE CORP. PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY 07/21/1977
K792019 PHARMASEAL DIV., BAXTER HEALTHCARE CORP. PHADECODE XA INHIBITOR ASSAY 11/05/1979
K023991 PRECISION BIOLOGIC CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 04/28/2003
K081769 SIEMENS HEALTHCARE DIAGNOSTICS INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 05/28/2009
K790090 SIGMA CHEMICAL CO. DETERMINATION OF ANTITHROMBIN III, 885 02/26/1979
K935308 SIGMA DIAGNOSTICS, INC. ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY 05/17/1994
K972144 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III 07/25/1997
K913667 THE BINDING SITE, LTD. ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT 01/03/1992
K884144 UNIPATH LTD. TURBOX ANTITHROMBIN III 12/20/1988
K850412 WARNER-LAMBERT CO. GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY 05/08/1985
K832592 WELLCOME DIAGNOSTICS DIACROM * ATIII 09/29/1983


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