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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
Nov 5, 1985K851153COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE
Astral Medical Systems
JPA
Oct 4, 1985K853789ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR
Hemotec, Inc.
JPA
Oct 4, 1985K853198ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES
Medical Device Consultants, Inc.
JPA
Sep 30, 1985K852450LODE COAGULOMETER MODEL LC-6
Lode Corp.
JPA
Aug 13, 1985K853246CALCIUM CHLORIDE
Bio/Data Corp.
JPA
Aug 12, 1985K853078CITREX III
Bio/Data Corp.
JPA
Aug 12, 1985K853077CITREX II
Bio/Data Corp.
JPA
Aug 12, 1985K853076CITREX I
Bio/Data Corp.
JPA
May 29, 1985K851127DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO
E.I. Dupont DE Nemours & Co., Inc.
JPA
May 8, 1985K850409GEN. DIAG. CHROMOSTRATE REF. PLASMA
Warner-Lambert Co.
JPA
Oct 17, 1984K842717COBAS-FIBRO
Roche Diagnostic Systems, Inc.
JPA
Jun 1, 1984K841523OWREN'S VERONAL BUFFERR
Diatech, Inc.
JPA
Jun 1, 1984K841462HEPARIN COAGULATION CONTROL PLASMA 1-
Diatech, Inc.
JPA
Nov 3, 1983K833272THROMBOPLASTIN - FS
American Dade
JPA
Aug 12, 1983K832225ORTHO ABNORMAL COAGULATION LEVEL I/II
Ortho Diagnostic Systems, Inc.
JPA
Nov 16, 1981K812121DIGICLOT 2-#820
Volu Sol Medical Industries
JPA
Nov 10, 1981K812122MULTI CLOT-#819
Volu Sol Medical Industries
JPA
Oct 2, 1981K812124MLA ELECTRA 700
Medical Laboratory Automation Systems, Inc.
JPA
Dec 4, 1979K792310NORM-TROL
Helena Laboratories
JPA
Sep 17, 1979K791586ELVI 818 DIGICLOT MULTISCAN
Volu Sol Medical Industries
JPA
Mar 21, 1979K790323COAG-A-MATE 2001
General Diagnostics
JPA
Mar 12, 1979K790204PLASMA, STANDARDIZED NORMAL
Dade, Baxter Travenol Diagnostics, Inc.
JPA
Jun 14, 1978K780810MLA ELECTRA 750 COAGULATION TIMER
Medical Laboratory Automation Systems, Inc.
JPA
May 6, 1977K770606ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH
Damon Corp.
JPA
Feb 1, 1977K761091TPC-LYOPHILIZED POOLED HUMAN PLASMA
Bio/Data Corp.
JPA
Jan 10, 1977K761176CALCIUM CHLORIDE (0.025M)
Bio/Data Corp.
JPA
Jan 10, 1977K761175IMIDAZOLE BUFFER (0.05M)
Bio/Data Corp.
JPA
Jan 10, 1977K761173TRIS BUFFERED
Bio/Data Corp.
JPA
Jan 10, 1977K761172TRIS BUFFERED SALINE
Bio/Data Corp.
JPA
Jan 10, 1977K761171VERONAL BUFFER
Bio/Data Corp.
JPA
Nov 24, 1976K760594AUTO-FI COAGULATION INSTRUMENT
Dade, Baxter Travenol Diagnostics, Inc.
JPA

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