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Panels › Hematology › Product code JPA · Class 2

System, Multipurpose For In Vitro Coagulation Studies

Regulation 864.5425

1510(k)s in 12 months (181 all time)
1recalls in 12 months (44 all time)
40recalls that name a 510(k)
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Top companies in JPA

Company510(k)sRecalls
Instrumentation Laboratory1211
Bio/Data Corp.130
Dade Behring, Inc.121
Diagnostica Stago, Inc.66
International Technidyne Corp.92
Haemonetics55
Helena Laboratories81
Sigma Diagnostics, Inc.80
Siemens Healthcare Diagnostics24
Siemens Healthcare Diagnostics Products GmbH60
Decided510(k)Device and applicantCode
Mar 28, 2002K020798HEMOCHRON JR. SIGNATURE +
International Technidyne Corp.
JPA
Nov 9, 2001K013114BCS SYSTEM
Dade Behring, Inc.
JPA
Aug 9, 2001K011665BCT SYSTEM
Dade Behring, Inc.
JPA
Jul 20, 2001K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
Dade Behring, Inc.
JPA
May 1, 2001K010494SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
Dade Behring, Inc.
JPA
Nov 16, 2000K002080BEHRING COAGULATION SYSTEM, MODEL BCS
Dade Behring, Inc.
JPA
Sep 14, 2000K002177THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
Haemoscope Corp.
JPA
Sep 6, 2000K994349COAGUCHEK S SYSTEM, MODEL 2138280
Roche Diagnostics Corp.
JPA
Aug 30, 2000K002400MODIFICATION OF ACL ADVANCE
Instrumentation Laboratory CO
JPA
Jun 21, 2000K001064BEHRING COAGULATION TIMER ANALYZER (BCT)
Dade Behring, Inc.
JPA
Jun 20, 2000K001067DADE BEHRING COAGULATION ANALYZER (BCT)
Dade Behring, Inc.
JPA
May 26, 2000K000973BEHRING COAGULATION SYSTEM (BCS)
Dade Behring, Inc.
JPA
May 5, 2000K993678THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
Haemoscope Corp.
JPA
Mar 15, 2000K000053ACL 9000 SYSTEM
Instrumentation Laboratory CO
JPA
Jan 11, 2000K992959BEHRING COAGULATION SYSTEM (BCS)
Dade Behring, Inc.
JPA
Jul 28, 1999K984501DADE BEHRING BFTII
Dade Behring, Inc.
JPA
May 14, 1999K990566TAS ANALYZER, MODEL 1009
Cardiovascular Diagnostics, Inc.
JPA
Apr 13, 1999K990449HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
International Technidyne Corp.
JPA
Apr 13, 1999K983892COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
Roche Diagnostics/Boehringer Mannheim GmbH
JPA
Nov 12, 1998K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
American Bioproducts Co.
JPA
Sep 30, 1998K981711SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
Dade Behring, Inc.
JPA
Sep 30, 1998K980839AVOCET PT
Avocet Medical, Inc.
JPA
Jul 30, 1998K981815HEPTRAC ELECTRONIC QUALITY CONTROL
Medtronic Blood Management
JPA
Jul 7, 1998K974799HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
International Technidyne Corp.
JPA
Jan 9, 1998K974569COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
Boehringer Mannheim Corp.
JPA
Oct 20, 1997K972260CS-400 COAGULATION ANALYZER SYSTEM (A1208)
Sigma Diagnostics, Inc.
JPA
May 5, 1997K970431BEHRING COAGULATION SYSTEM
Behring Diagnostics, Inc.
JPA
Mar 18, 1997K964946SYSMEX CA-1000/SYSMEX CA-5000
Sysmex Corp.
JPA
Dec 10, 1996K961908THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
Helena Laboratories
JPA
Sep 10, 1996K960875KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
Sigma Diagnostics, Inc.
JPA
Jun 20, 1996K954202PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
Medtronic Hemotec, Inc.
JPA
Mar 13, 1996K955720AMAX CS-190 COAGULATION ANALYZER SYSTEM
Sigma Diagnostics, Inc.
JPA
Mar 12, 1996K955724KC 1A COAGULATION ANALYZER/SET
Sigma Diagnostics, Inc.
JPA
Mar 11, 1996K955735KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
Sigma Diagnostics, Inc.
JPA
Nov 21, 1995K952625COAGUCHEK SYSTEM
Boehringer Mannheim Corp.
JPA
Nov 3, 1995K951891ACL FUTURA COAGULATION SYSTEM
Instrumentation Laboratory CO
JPA
Sep 5, 1995K952560SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER
Sienco, Inc.
JPA
Sep 1, 1995K951497CASCASE 480 SNSLYZER
Helena Laboratories
JPA
Apr 18, 1995K926551BEHRING FIBRINTIMER A
Behring Diagnostics, Inc.
JPA
Mar 24, 1995K942097TOA MEDICAL ELECTRONICS CA-5000
Sysmex Corp.
JPA
Mar 24, 1995K942096TOA MEDICAL ELECTRONICS CA-1000
Sysmex Corp.
JPA
Oct 18, 1994K940957HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
International Technidyne Corp.
JPA
Jul 19, 1994K940840ACT CONTROL SET
Sigma Diagnostics, Inc.
JPA
May 11, 1994K940401JR. MICROCOAGULATION SYSTEM
International Technidyne Corp.
JPA
Jan 27, 1994K933886TOA MEDICAL ELECTRONICS CA-5000
Toa Medical Electronics USA, Inc.
JPA
Dec 3, 1993K934747R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
R & D Batteries, Inc.
JPA
Nov 3, 1993K931149CA-1000 AUTOMATED COAGULATION ANALYZER
Toa Medical Electronics USA, Inc.
JPA
Sep 22, 1993K933188DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
Baxter Diagnostics, Inc.
JPA
Sep 2, 1993K930068HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION
Technidyne Corp.
JPA
Aug 5, 1993K930454BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
Boehringer Mannheim Corp.
JPA

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