Panels › Hematology › Product code GGP · Class 2
Test, Qualitative And Quantitative Factor Deficiency
Regulation 864.7290
0510(k)s in 12 months (190 all time)
2recalls in 12 months (14 all time)
12recalls that name a 510(k)
Top companies in GGP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 26, 1998 | K981200 | IL TEST PLASMINOGEN Instrumentation Laboratory CO | GGP |
| May 1, 1998 | K974711 | COAMATIC PLASMINOGEN Instrumentation Laboratory CO | GGP |
| Apr 21, 1998 | K980875 | IL TEST PROTEIN C Instrumentation Laboratory CO | GGP |
| Apr 16, 1998 | K981038 | COAMATIC FACTOR VIII Instrumentation Laboratory CO | GGP |
| Oct 20, 1997 | K971985 | N-ASSAY TIA PLASMINOGEN TEST KIT Crestat Diagnostics, Inc. | GGP |
| Oct 6, 1997 | K972342 | REAADS PROTEIN C ANTIGEN TEST KIT Reaads Medical Products, Inc. | GGP |
| Sep 25, 1997 | K973143 | UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA Universal Reagents, Inc. | GGP |
| Aug 19, 1997 | K971519 | ASSERACHROM TPA TEST KIT American Bioproducts Co. | GGP |
| Aug 13, 1997 | K972482 | REAADS PROTEIN S ANTIGEN TEST KIT Reaads Medical Products, Inc. | GGP |
| Aug 13, 1997 | K972005 | REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT Reaads Medical Products, Inc. | GGP |
| Jul 25, 1997 | K972116 | VON WILLEBRAND REAGENT Behring Diagnostics, Inc. | GGP |
| Jul 14, 1997 | K972288 | FACTOR DEFICIENT PLASMAS - FACTOR IX (9) Universal Reagents, Inc. | GGP |
| Apr 21, 1997 | K951640 | HUMAN PROTEIN S RID TEST KIT The Binding Site, Ltd. | GGP |
| Dec 18, 1996 | K964459 | UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA Universal Reagents, Inc. | GGP |
| Dec 18, 1996 | K964270 | UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA Universal Reagents, Inc. | GGP |
| Dec 13, 1996 | K962968 | PROC APC ASSAY, PROC CONTROL PLASMA Behring Diagnostics, Inc. | GGP |
| Nov 18, 1996 | K963106 | CHROMOLIZE PAI-1 KIT Medical Diagnostic Technologies, Inc. | GGP |
| Nov 15, 1996 | K962825 | SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY Shield Diagnostics, Ltd., GB | GGP |
| Oct 10, 1996 | K961929 | FACTOR DEFICIENT PLASMA Universal Reagents, Inc. | GGP |
| Jul 31, 1996 | K962489 | CHROMOLIZE TPA ASSAY KIT Medical Diagnostic Technologies, Inc. | GGP |
| Jun 5, 1996 | K960438 | TINTELIZE PAI-1 KIT Medical Diagnostic Technologies, Inc. | GGP |
| Feb 29, 1996 | K955738 | BIOCLOT PROTEIN S Medical Diagnostic Technologies, Inc. | GGP |
| Feb 29, 1996 | K952126 | AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II Aalto Scientific, Ltd. | GGP |
| Feb 9, 1996 | K952668 | CHROM Z-F:VIII, CAT. NO. 5241 Helena Laboratories | GGP |
| Jan 30, 1996 | K952666 | CHROM Z-PROTEIN C, CAT. NO. 5243 Helena Laboratories | GGP |
| Dec 7, 1995 | K952669 | CHROM Z-PLASMINOGEN, CAT. NO. 5244 Helena Laboratories | GGP |
| Nov 13, 1995 | K954040 | ASSERACHROM TOTAL PROTEIN S KIT American Bioproducts Co. | GGP |
| Nov 13, 1995 | K954017 | ASSERACHROM FREE PROTEIN S KIT American Bioproducts Co. | GGP |
| Nov 6, 1995 | K943225 | COAMATIC FACTOR VIII Pharmacia Hepar, Inc. | GGP |
| Sep 25, 1995 | K941752 | SPECTROLYSE ANTIPLASMIN KIT Biopool AB, CA | GGP |
| Jul 13, 1995 | K942087 | BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES Biopool AB, CA | GGP |
| Mar 6, 1995 | K950015 | HUMAN PROTEIN C RID TEST KIT Jay H. Geller | GGP |
| Jan 24, 1995 | K924425 | PROTEIN C REAGENT, COAGULOMETRIC Behring Diagnostics, Inc. | GGP |
| Jan 11, 1995 | K945414 | RISTOCETIN COFACTOR ASSAY KIT Chrono-Log Corp. | GGP |
| Dec 22, 1994 | K934210 | HEMOLAB PROTEIN C CHROMOGENIC ASSAY Biomerieux Vitek, Inc. | GGP |
| Feb 23, 1994 | K934314 | TINTELIZER(R) TPA Biopool AB, CA | GGP |
| Jan 27, 1994 | K925617 | MDA PROTEIN ASSAY Organon Teknika Corp. | GGP |
| Dec 6, 1993 | K934584 | SPECTROLYSE FACTOR VII:C Meditech, Inc. | GGP |
| Nov 5, 1993 | K931906 | NEW STACHROM PROTEIN C TEST KIT American Bioproducts Co. | GGP |
| Sep 2, 1993 | K930235 | HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY Technidyne Corp. | GGP |
| Apr 12, 1993 | K930327 | IL TEST(TM) PROTEIN S Instrumentation Laboratory CO | GGP |
| Jan 14, 1993 | K924884 | IL TEST(TM) PRO-CHROM Instrumentation Laboratory CO | GGP |
| Dec 7, 1992 | K922201 | COAMATE PROTEIN C CHROMOGENIC ASSAY Chromogenix AB, SE | GGP |
| Oct 9, 1992 | K922782 | SPECTROLYSE/PL PAI KIT Biopool AB, CA | GGP |
| Sep 23, 1992 | K921449 | NEW STACHROM ANTIPLASMIN American Bioproducts Co. | GGP |
| Aug 12, 1992 | K920012 | IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM Instrumentation Laboratory CO | GGP |
| Apr 17, 1992 | K920981 | RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA Medical Diagnostic Technologies, Inc. | GGP |
| Jan 15, 1992 | K914818 | DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY Baxter Diagnostics, Inc. | GGP |
| Jan 6, 1992 | K915163 | PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES Biopool AB, CA | GGP |
| Dec 9, 1991 | K914307 | SPECTROLYSE PROTEIN C KIT Biopool AB, CA | GGP |
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