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Panels › Hematology › Product code GJS · Class 2

Test, Time, Prothrombin

Regulation 864.7750

0510(k)s in 12 months (127 all time)
0recalls in 12 months (73 all time)
68recalls that name a 510(k)
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Top companies in GJS

Company510(k)sRecalls
Roche Diagnostics148
Instrumentation Laboratory CO118
Alere San Diego014
International Technidyne Corp.85
Roche Diagnostics Operations, Inc.010
Diagnostica Stago, Inc.09
Helena Laboratories60
Abbott Point Of Care Inc.05
BIOMERIEUX, INC.05
Hemosense, Inc.32
Decided510(k)Device and applicantCode
Sep 13, 1988K883441VISION(R) PROTHROMBIN TIME
Abbott Laboratories
GJS
Aug 25, 1988K882456COAG-I PT TEST CARD
Cardiovascular Diagnostic Services
GJS
Jul 1, 1988K882214SIMPLASTIN EXCEL S
Organon Teknika Corp.
GJS
Mar 23, 1988K880566CLP PROTHROMBIN TIME TEST
Creative Laboratory Products, Inc.
GJS
Feb 11, 1988K875062EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
Em Diagnostic Systems, Inc.
GJS
Feb 4, 1988K874592THROMBOPLASTIN.C
Baxter Healthcare Corp
GJS
Aug 27, 1987K872537PROTHROMBIN TIME TEST
Sclavo, Inc.
GJS
Aug 6, 1987K872844THROMBOREL S
Behring Diagnostics, Inc.
GJS
Apr 20, 1987K870596PROTHROMBIN TIME TEST
U. S. Diagnostics, Inc.
GJS
Jan 5, 1987K864392PROTIME AUTOMATE TEST KIT
American Bioproducts Co.
GJS
Dec 4, 1986K864283SIMPLASTIN EXCEL
Organon Teknika Corp.
GJS
Nov 13, 1986K864274THROMBOPLASTIN.R
American Dade
GJS
Nov 13, 1986K864273THROMBOPLASTIN.C
American Dade
GJS
Nov 13, 1986K864272THROMBOPLASTIN.FS
American Dade
GJS
May 23, 1986K860721BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST
Biotrack, Inc.
GJS
Aug 12, 1985K852484PLASTINEX
Bio/Data Corp.
GJS
May 29, 1985K851125ACA PROTHROMBIN TIME ANALYTICAL TEST PACK
E.I. Dupont DE Nemours & Co., Inc.
GJS
Dec 12, 1984K843535ORTHO BRAIN THROMBOPLASTIN DILUENT
Ortho Diagnostic Systems, Inc.
GJS
May 1, 1984K840802DIA THROMBIN DIA PLASTIN
Diatech, Inc.
GJS
Oct 14, 1983K832427EASYTOUCH TROMBOPLASTIN REAGENT
Worthington Diagnostic Systems
GJS
Apr 5, 1983K830331LIQUID THROMBOPLASTIN REAGENT
Helena Laboratories
GJS
Jul 27, 1981K811784SIGMA PROCEDURE #890
Sigma Chemical Co.
GJS
Apr 14, 1981K810350THROMBOPLASTIN
Pacific Hemostasis
GJS
Nov 5, 1979K792031LANCER COAGENT PT KIT
Sherwood Medical Co.
GJS
Jul 24, 1979K791022PROTHROMBIN REFERENCE PLASMA (HUMAN)
Pacific Hemostasis
GJS
Jun 28, 1979K791023PROTHROMBIN FREE BEEF PLASMA (PFB)
Pacific Hemostasis
GJS
Mar 27, 1978K780203THROMBOPLASTIN DRIED
Hyland Therapeutic Div., Travenol Laboratories
GJS

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