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181 FDA 510(k) clearances · Product code

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RecordFirmDate
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA (K930849)Organon Teknika Corp.1993-04-20
COAGULATION CONTROL CONTAINING HEMOGLOBIN (K925340)Analytical Control Systems, Inc.1993-03-23
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 (K926222)Helena Laboratories1993-02-12
ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM (K923761)International Technidyne Corp.1993-01-21
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION (K924509)Behring Diagnostics, Inc.1992-12-21
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180) (K924453)Organon Teknika Corp.1992-12-18
BEHRING FIBRINTIMER A (K924124)Behring Diagnostics, Inc.1992-12-01
STANDARD HUMAN PLASMA (K924393)Behring Diagnostics, Inc.1992-11-16
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM (K914188)Ortho Diagnostic Systems, Inc.1992-08-26
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS (K912087)Instrumentation Laboratory CO1991-09-19
HEPARIN ADSORBENT (K912061)Sigma Diagnostics, Inc.1991-07-24
ACS 0.02 M CALCIUM CHLORIDE (K902458)Analytical Control Systems, Inc.1990-08-01
COAG-A-MATE - RA4 (K900917)Organon Teknika Corp.1990-04-16
MODIFIED COATRON II AND COATRON JR. (K900506)Astral Medical Systems1990-03-12
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN (K900377)Baxter Healthcare Corp1990-03-06
CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS (K894359)Hemotec, Inc.1989-09-05
HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS (K894466)Hemotec, Inc.1989-09-05
PLATELET AGGREGATION PROFILER MODEL PAP-4C (K893650)Bio/Data Corp.1989-06-23
PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER (K884534)Pall Biomedical Products Co.1989-01-24
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE (K885076)Organon Teknika Corp.1988-12-30
ORTHO OWREN'S BUFFER (K883689)Ortho Diagnostic Systems, Inc.1988-11-01
KD 0.1 M SODIUM CITRATE SOLUTION (K883635)King Diagnostics, Inc.1988-10-31
KD 0.02 M CALCIUM CHLORIDE SOLUTION (K883637)King Diagnostics, Inc.1988-10-31
KD ONE-STAGE PROTHROMBIN TIME TEST (K883640)King Diagnostics, Inc.1988-10-31
COAG-I ANALYZER, ALPHA MODEL (K882444)Cardiovascular Diagnostic Services1988-08-25
OWREN'S VERONAL BUFFER (K883484)Helena Laboratories1988-08-25
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS (K881367)Instrumentation Laboratory CO1988-06-27
CLP 0.1 M SODIUM CITRATE SOLUTION (K880713)Creative Laboratory Products, Inc.1988-03-18
HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN (K875089)Hemotec, Inc.1988-03-09
CHROM-TROL (K872377)Helena Laboratories1987-07-09
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA (K870831)International Technidyne Corp.1987-06-01
PT HEPARIN ADSORBENT (K870771)Probe-Tek, Inc.1987-04-23
COAGULATION CONTROL, LEVEL III (K870687)U. S. Diagnostics, Inc.1987-04-20
COAGULATION CONTROL, LEVEL I (K870685)U. S. Diagnostics, Inc.1987-04-20
COAGULATION CONTROL, LEVEL II (K870686)U. S. Diagnostics, Inc.1987-04-20
O.O2 M CALCIUM CHLORIDE SOLUTION (K870688)U. S. Diagnostics, Inc.1987-03-31
COAG-A-MATE(R) XC (K870960)Organon Teknika Corp.1987-03-17
ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER (K864534)Medical Laboratory Automation Systems, Inc.1987-02-06
ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER (K864532)Medical Laboratory Automation Systems, Inc.1987-02-06
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA (K864271)Instrumentation Laboratory CO1986-11-25
KOAGULAB* M COAGULATION SYSTEM (K862537)Ortho Diagnostic Systems, Inc.1986-07-21
BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) (K860719)Biotrack, Inc.1986-05-23
COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. (K854938)Diatech, Inc.1986-03-12
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP (K860342)Bio/Data Corp.1986-03-04
MICROSAMPLE COAGULATION ANALYSER MODEL 110P (K854546)Bio/Data Corp.1986-01-07
DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT (K854090)Diatech, Inc.1986-01-06
DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT (K854089)Diatech, Inc.1986-01-06
HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS (K854376)Hemotec, Inc.1985-12-04
THROMBOPLASTIN-R REAGENT (K853986)American Dade1985-11-12
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS (K853328)Ortho Diagnostic Systems, Inc.1985-11-05
COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE (K851153)Astral Medical Systems1985-11-05
ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR (K853789)Hemotec, Inc.1985-10-04
ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES (K853198)Medical Device Consultants, Inc.1985-10-04
LODE COAGULOMETER MODEL LC-6 (K852450)Lode Corp.1985-09-30
CALCIUM CHLORIDE (K853246)Bio/Data Corp.1985-08-13
CITREX II (K853077)Bio/Data Corp.1985-08-12
CITREX I (K853076)Bio/Data Corp.1985-08-12
CITREX III (K853078)Bio/Data Corp.1985-08-12
DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO (K851127)E.I. Dupont DE Nemours & Co., Inc.1985-05-29
GEN. DIAG. CHROMOSTRATE REF. PLASMA (K850409)Warner-Lambert Co.1985-05-08
COBAS-FIBRO (K842717)Roche Diagnostic Systems, Inc.1984-10-17
HEPARIN COAGULATION CONTROL PLASMA 1- (K841462)Diatech, Inc.1984-06-01
OWREN'S VERONAL BUFFERR (K841523)Diatech, Inc.1984-06-01
THROMBOPLASTIN - FS (K833272)American Dade1983-11-03
ORTHO ABNORMAL COAGULATION LEVEL I/II (K832225)Ortho Diagnostic Systems, Inc.1983-08-12
DIGICLOT 2-#820 (K812121)Volu Sol Medical Industries1981-11-16
MULTI CLOT-#819 (K812122)Volu Sol Medical Industries1981-11-10
MLA ELECTRA 700 (K812124)Medical Laboratory Automation Systems, Inc.1981-10-02
NORM-TROL (K792310)Helena Laboratories1979-12-04
ELVI 818 DIGICLOT MULTISCAN (K791586)Volu Sol Medical Industries1979-09-17
COAG-A-MATE 2001 (K790323)General Diagnostics1979-03-21
PLASMA, STANDARDIZED NORMAL (K790204)Dade, Baxter Travenol Diagnostics, Inc.1979-03-12
MLA ELECTRA 750 COAGULATION TIMER (K780810)Medical Laboratory Automation Systems, Inc.1978-06-14
ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH (K770606)Damon Corp.1977-05-06
TPC-LYOPHILIZED POOLED HUMAN PLASMA (K761091)Bio/Data Corp.1977-02-01
VERONAL BUFFER (K761171)Bio/Data Corp.1977-01-10
IMIDAZOLE BUFFER (0.05M) (K761175)Bio/Data Corp.1977-01-10
TRIS BUFFERED SALINE (K761172)Bio/Data Corp.1977-01-10
CALCIUM CHLORIDE (0.025M) (K761176)Bio/Data Corp.1977-01-10
TRIS BUFFERED (K761173)Bio/Data Corp.1977-01-10
AUTO-FI COAGULATION INSTRUMENT (K760594)Dade, Baxter Travenol Diagnostics, Inc.1976-11-24
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