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)
Top companies in GJS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 1999 | K991065 | CARESIDE PT Careside, Inc. | GJS |
| Sep 30, 1998 | K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT International Technidyne Corp. | GJS |
| Jul 22, 1998 | K974343 | DADE INNOVIN Dade Intl., Inc. | GJS |
| Jul 7, 1998 | K981479 | IL TEST PT-FIBRINOGEN RECOMBINANT Instrumentation Laboratory CO | GJS |
| Feb 24, 1998 | K974566 | MDA SIMPLASTIN HTF Organon Teknika Corp. | GJS |
| Oct 10, 1997 | K972796 | SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM Sigma Diagnostics, Inc. | GJS |
| Apr 22, 1997 | K962571 | COAGUCHEK PST SYSTEM Boehringer Mannheim Corp. | GJS |
| Mar 12, 1997 | K961835 | PROTIME MICROCOAGULATION SYSTEM International Technidyne Corp. | GJS |
| Jun 28, 1996 | K961938 | STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS Nova Biomedical Corp. | GJS |
| Mar 18, 1996 | K955843 | TAS PTONE Cardiovascular Diagnostic Services | GJS |
| Mar 11, 1996 | K954625 | PROTHROMBIN TIME TEST CARD Cardiovascular Diagnostics, Inc. | GJS |
| Oct 20, 1995 | K951820 | THROMBOPLASTIN-LI REAGENT Helena Laboratories | GJS |
| Oct 6, 1995 | K952608 | MDA SIMPLASTIN LS Organon Teknika Corp. | GJS |
| May 11, 1995 | K942884 | COAGUCHEK SYSTEM Boehringer Mannheim Corp. | GJS |
| Apr 28, 1995 | K945078 | HEMOCHRON HNPT/FACTOR VI PT+ International Technidyne Corp. | GJS |
| Apr 26, 1995 | K935748 | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT Ortho Diagnostic Systems, Inc. | GJS |
| Feb 14, 1995 | K940082 | THROMBOSCREEN THROMBOPLASTIN-DS Pacific Hemostasis | GJS |
| Nov 22, 1994 | K935702 | DADE INNOVIN II Baxter Diagnostics, Inc. | GJS |
| May 18, 1994 | K940432 | MICROCOAGULATION PROTHROMBIN TIME TEST International Technidyne Corp. | GJS |
| Apr 20, 1994 | K940310 | HELENA THROMBOPLASTIN-MI REAGENT Helena Laboratories | GJS |
| Mar 30, 1994 | K931118 | ASSESS(TM) HIGH ABNORMAL CONTROL Instrumentation Laboratory CO | GJS |
| Mar 30, 1994 | K931117 | ASSESS(TM) LOW ABNORMAL CONTROL Instrumentation Laboratory CO | GJS |
| Oct 4, 1993 | K933252 | IL TEST (TM) PT-FIBRINOGEN HS PLUS Instrumentation Laboratory CO | GJS |
| May 11, 1993 | K930212 | THROMBOPLATIN-M WITH CALCIUM Sigma Diagnostics, Inc. | GJS |
| Mar 12, 1993 | K925604 | ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT Ortho Diagnostic Systems, Inc. | GJS |
| Feb 12, 1993 | K920767 | NYCOPLASTIN Nycomed Pharma AS, NO | GJS |
| Feb 3, 1993 | K925492 | BIOMERIEUX HEMOLAB THROMBOMAT Biomerieux Vitek, Inc. | GJS |
| Dec 7, 1992 | K922565 | NEOPLASTINE(R) CI KIT American Bioproducts Co. | GJS |
| Jul 27, 1992 | K921326 | DADE RECOMBOPLASTIN S Baxter Diagnostics, Inc. | GJS |
| Jun 23, 1992 | K922040 | NEOPLASTINE CI PLUS American Bioproducts Co. | GJS |
| Feb 12, 1992 | K915746 | SIMPLASTIN L Organon Teknika Corp. | GJS |
| Dec 4, 1991 | K913249 | ACS ULTRA-1 THROMBOPLASTIN Analytical Control Systems, Inc. | GJS |
| Nov 27, 1991 | K913250 | ACS ULTRA-2 THROMBOPLASTIN Analytical Control Systems, Inc. | GJS |
| Aug 9, 1991 | K912102 | ACS LIQUID THROMBOPLASTIN Analytical Control Systems, Inc. | GJS |
| Jul 17, 1991 | K911995 | PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION International Technidyne Corp. | GJS |
| Apr 16, 1991 | K905807 | HELENA THROMBOPLASTIN REAGENT WITH DILUENT Helena Laboratories | GJS |
| Feb 27, 1991 | K905857 | HELENA THROMBOPLASTIN REAGENT, MODIFICATION Helena Laboratories | GJS |
| Jan 25, 1991 | K904325 | COAG-1 PT-NC TEST CARD Cardiovascular Diagnostic Services | GJS |
| Dec 17, 1990 | K904454 | HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION International Technidyne Corp. | GJS |
| Aug 10, 1990 | K902468 | ACS ONE-STAGE PROTHROMBIN TIME REAGENT Analytical Control Systems, Inc. | GJS |
| Aug 1, 1990 | K903019 | MODIFIED COAG-1 PT TEST CARD Cardiovascular Diagnostic Services | GJS |
| Jul 3, 1990 | K902096 | THROMBOPLASTIN WITH CALCIUM Sigma Chemical Co. | GJS |
| May 2, 1990 | K901325 | THROMBOPLASTIN.C PLUS Baxter Healthcare Corp | GJS |
| Dec 11, 1989 | K896625 | THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. Medical Diagnostic Technologies, Inc. | GJS |
| Jun 23, 1989 | K885107 | THROMBOSTIN IFA* Investigacion Farmaceutica S.A. DE C.V., MX | GJS |
| Jun 22, 1989 | K893378 | PROTHROMBIN TIME (PT) BY HEMOCHRON International Technidyne Corp. | GJS |
| Jun 7, 1989 | K892050 | HELENA THROMBOPLASTIN REAGENT Helena Laboratories | GJS |
| Apr 21, 1989 | K891370 | EDL ONE-STAGE PROTHROMBIN TIME REAGENT Elite Diagnostic , Ltd. | GJS |
| Apr 10, 1989 | K891169 | DADE THROMBOPLASTIN IS Baxter Healthcare Corp | GJS |
| Jan 30, 1989 | K884855 | THROMBOPLASTIN Precision Biologicals, Inc., CA | GJS |
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