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GGP

190 FDA 510(k) clearances · Product code

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RecordFirmDate
IL TEST PROCLOT ASSAY STYSTEM (K912711)Instrumentation Laboratory CO1991-10-09
STACLOT(R) PROTEIN S TEST KIT (K913424)American Bioproducts Co.1991-10-08
LIATEST PROTEIN S KIT (K912468)American Bioproducts Co.1991-10-02
SPECTROLYSE PLASMINOGEN SK KIT (K912025)Biopool AB1991-08-22
DADE PROTEIN C CLOTTING ASSAY (K903468)Baxter Healthcare Corp1991-02-26
FREE PROTEIN S REAGENT CAT. NO. 5363 (K904247)Helena Laboratories1991-01-18
BIOPOOL PROTEIN C EID KIT AND BULK PLATES (K902566)Biopool AB1990-08-09
BIOCLOT C KIT (K902528)Biopool AB1990-08-09
ORTHOKROME* FACTOR VIII (K900395)Ortho Diagnostic Systems, Inc.1990-03-15
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359 (K896174)Helena Laboratories1990-03-15
ORTHOKROME* ANTIPLASMIN (K900397)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* PROTEIN C (K900398)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* PLASMINOGEN (K900399)Ortho Diagnostic Systems, Inc.1990-03-15
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357 (K897136)Helena Laboratories1990-02-05
THE STAGO VIII DEFICIENT PLASMA KIT (K892859)American Bioproducts Co.1989-06-23
BERICHROM PROTEIN C KIT (K890634)Behring Diagnostics, Inc.1989-04-21
BERICHROM ALPHA-2-ANTIPLASMIN (K884797)Behring Diagnostics, Inc.1989-04-21
ACTICLOT C KIT (K884941)American Diagnostic Corp.1989-03-13
RELLPLATE C KIT, RELLPLATE C BULK PLATES (K884940)American Diagnostic Corp.1989-03-13
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY (K890409)Baxter Healthcare Corp1989-02-27
DADE PROTEIN C CHROMOGENIC ASSAY (K884881)Baxter Healthcare Corp1989-02-02
DADE FACTOR IX CHROMOGENIC ASSAY (K884551)Baxter Healthcare Corp1988-12-30
DADE FACTOR VIII CHROMOGENIC ASSAY (K884544)Baxter Healthcare Corp1988-12-30
COATEST PROTEIN C (K884058)Kabivitrum, Inc.1988-12-13
STACHROM ANTIPLASMIN TEST KIT (K882602)American Bioproducts Co.1988-09-02
STACHROM ANTIPLASMIN CONTROL (K882603)American Bioproducts Co.1988-09-02
SPECTROLYSE/FIBRIN (K881037)Cytrx Biopool, Ltd.1988-07-01
CALIBRATION REFERENCE PLASMA (K874940)Baxter Healthcare Corp1988-02-09
STACHROM VIII:C TEST KIT (K874097)American Bioproducts Co.1987-12-03
SPECTRO C (K872941)Ramco Laboratories, Inc.1987-09-04
ASSERACHROM PROTEIN S TEST KIT (K872479)American Bioproducts Co.1987-08-21
STACHROM PROTEIN C TEST KIT (K871039)American Bioproducts Co.1987-05-21
PROTEIN S CONTROL PLASMA (K870917)American Bioproducts Co.1987-04-23
VWF IMMUNOBLOT (K864701)Ramco Laboratories, Inc.1987-03-30
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN) (K870353)American Dade1987-02-10
IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) (K870354)American Dade1987-02-10
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA (K864480)Instrumentation Laboratory CO1987-01-21
COAGULATION EXTRINSIC DEFICIENT PLASMAS (K864497)Instrumentation Laboratory CO1987-01-05
COAGULATION INTRINSIC DEFICIENT PLASMAS (K864481)Instrumentation Laboratory CO1987-01-05
ASSERA-PLATE PROTEIN C KIT (K861475)American Bioproducts Co.1986-06-25
ASSERA-PLATE VWF KIT (K861417)American Bioproducts Co.1986-06-25
STACLOT PROTEIN C TEST KIT (K861079)American Bioproducts Co.1986-06-19
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA (K861049)Sigma Chemical Co.1986-05-29
PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765 (K861048)Sigma Chemical Co.1986-05-29
VWF-IX:AG CONTROL PLASMA (K861217)American Bioproducts Co.1986-05-20
PROTEIN C CONTROL PLASMA (K861216)American Bioproducts Co.1986-05-16
SPECTRO VWF (K861159)Ramco Laboratories, Inc.1986-05-01
ASSERACHROM VWF KIT (K860371)American Bioproducts Co.1986-04-04
ASSERACHROM IX:AG (K854312)American Bioproducts Co.1986-02-04
ASSERA PLATE IX:AG KIT (K854014)American Bioproducts Co.1986-01-03
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA (K853462)American Dade1985-08-29
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA (K853461)American Dade1985-08-29
FACTOR X DEFICIENT PLASMA, BLOD HUMAN (K843310)Sigma Chemical Co.1984-11-19
FACTOR IX DEFICIENT PLASMA, B9D - (K843215)Sigma Chemical Co.1984-11-19
FACTOR XI DEFICIENT PLASMA B11D (K843438)Sigma Chemical Co.1984-11-19
FACTOR XII DEFICIENT PLASMA B12D (K843451)Sigma Chemical Co.1984-11-19
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT (K842617)American Dade1984-10-01
MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII (K841708)Meloy Laboratories, Inc.1984-07-19
BOVINE FACTOR XA-HUMAN FACTOR XA (K841957)Haemachem, Inc.1984-07-19
COAGULATION CONTROL PLASMA LEVEL 1/2/3 (K841461)Diatech, Inc.1984-05-02
FACTOR DEFICIENT SUBSTRATE PLASMA II (K840927)Diatech, Inc.1984-04-30
FACTOR DEFICIENT SUBSTRATE PLASMA VIII (K840928)Diatech, Inc.1984-04-30
COAGULATION FACTOR V DEFICIENT SUBSTR (K841364)American Dade1984-04-25
RISTOCETIN COFACTOR ASSAY (K840329)Helena Laboratories1984-04-05
COAGULATION FACTOR DEFICIENT PLASMA (K840114)Medical Specialties Laboratories1984-02-04
PROTOPATH FACTOR VIII ASSAY (K834051)American Dade1984-02-04
PROTOPATH FACTOR IX ASSAY (K834050)American Dade1984-02-04
COATEST FACTOR VIII (K833892)Kabivitrum, Inc.1984-01-30
FACTOR II DEFICIENT SUBSTRATE PLASMA (K834031)Helena Laboratories1983-12-16
DIACROM * FACTOR X KIT HA31 (K832372)Wellcome Diagnostics1983-09-29
COATEST FACTOR X (K832114)Kabivitrum, Inc.1983-08-26
VON WILLEBRAND FACTOR ASSAY (K823453)General Diagnostics1983-01-21
FACTOR VIII RELATED ANTIGEN ROCKET EID (K823267)Helena Laboratories1982-12-28
EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. (K821963)Intl. Immunoassay Laboratories, Inc.1982-07-27
DADE FACTOR ASSAY REFERENCE PLASMA (K820085)American Dade1982-02-23
LANCER COAGENT HUMAN VACTOR VIII PLASMA (K812975)Sherwood Medical Co.1981-11-16
LANCER COAGENT HUMAN FACTOR 1X PLASMA (K812974)Sherwood Medical Co.1981-11-16
FACTOR VIII DEFICIENT PLASMA #B8D (K812431)Sigma Chemical Co.1981-09-23
VON WILLEBRAND FACTOR ASSAY (K802356)Bio/Data Corp.1980-12-01
HELENA FACTOR XII DEFICIENT (K792656)Helena Laboratories1980-01-24
HELENA FACTOR XI DEFICIENT SUBSTRATE (K792476)Helena Laboratories1979-12-31
HELENA FACTOR V DEFICIENT SUBSTRATE (K792507)Helena Laboratories1979-12-31
HELENA FACTOR VII DEFICIENT SUB. PLASMA (K792511)Helena Laboratories1979-12-31
HELENA FACTOR IX DEFICIENT SUBSTRATE (K792475)Helena Laboratories1979-12-31
HELENA FACTOR X DEFICIENT SUBSTRATE (K792508)Helena Laboratories1979-12-31
HELENA FACTOR II DEFICIENT SUB. PLASMA (K792336)Helena Laboratories1979-12-27
HELENA FACTOR VIII DEFICIENT SUB. PLASMA (K792335)Helena Laboratories1979-12-04
FACTOR VII DEFICIENT PLASMA (K791794)Sigma Chemical Co.1979-10-01
FACTOR V DEFICIENT (K790423)Sigma Chemical Co.1979-04-04
QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT (K761058)Bio/Data Corp.1977-02-07
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