Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- GKFInstrument, Hematocrit, Automated2Product Code
- GKHApparatus, Automated Blood Cell Diluting1Product Code
- GKJSpinner, Slide, Automated1Product Code
- GKLCounter, Cell, Automated (Particle Counter)2Product Code
- GKNTimer, Clot, Automated2Product Code
- GIZPlasma, Control, Normal2Product Code
- GKBDevice, Automated Sedimentation Rate1Product Code
- GGCControl, Plasma, Abnormal2Product Code
- GGNPlasma, Coagulation Control2Product Code
- GHKCentrifuge, Microsedimentation1Product Code
- GHRReagent, Platelet Aggregation2Product Code
- GIEFibrometer2Product Code
- GKPInstrument, Coagulation, Automated2Product Code
- GKRSystem, Hemoglobin, Automated2Product Code
- GKXInstrument, Automated Platelet Counting2Product Code
- GKZCounter, Differential Cell2Product Code
- JBTTimer, Coagulation2Product Code
- JBWRed-Cell Indices, Measured2Product Code
- JOXAnalyzer, Heparin, Automated2Product Code
- JOYDevice, Automated Cell-Locating2Product Code
- JOZSystem, Automated Platelet Aggregation2Product Code
- JPASystem, Multipurpose For In Vitro Coagulation Studies2Product Code
- K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge2Cleared 510(K)
- K232018Citrated: K, KH, RTH, FFH2Cleared 510(K)
- K233790ACL TOP 970 CL2Cleared 510(K)
- K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM2Cleared 510(K)
- K212183STA R Max 3, STA Compact Max 32Cleared 510(K)
- K201440ROTEM sigma Thromboelastometry System2Cleared 510(K)
- K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 22Cleared 510(K)
- K193041Hemochron Signature Elite2Cleared 510(K)
- K183390QNext and DG-PT2Cleared 510(K)
- K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge2Cleared 510(K)
- K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set2Cleared 510(K)
- K172286Automated Blood Coagulation Analyzer CS-25002Cleared 510(K)
- K172333Sysmex CS-51002Cleared 510(K)
- K160502TEG 6s Hemostasis System2Cleared 510(K)
- K170314ACL AcuStar2Cleared 510(K)
- K162688Sysmex CS-2100i2Cleared 510(K)
- K162420Sysmex Automated Blood Coagulation Analyzer CS-51002Cleared 510(K)
- K161317Sysmex Automated Blood Coagulation Analyzer CS-51002Cleared 510(K)
- K161312Sysmex Automated Blood Coagulation Analyzer CS-2100i2Cleared 510(K)
- K151259Sysmex Automated Blood Coagulation Analyzer CS-2100i2Cleared 510(K)
- K150678Sysmex Automated Blood Coagulation Analyzer CS-51002Cleared 510(K)
- K151867STA R MAX2Cleared 510(K)
- K150041CORA (Coagulation Resonance Analysis) System2Cleared 510(K)
- K130090STA COMPACT MAX2Cleared 510(K)
- K101533EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM2Cleared 510(K)
- K083842ROTEM DELTA THROMBOELASTOMETRY SYSTEM2Cleared 510(K)
- K093167STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER2Cleared 510(K)
- K093001STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER2Cleared 510(K)
- K083896DESTINY MAX COAGULATION ANALYZER2Cleared 510(K)
- K083518ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS2Cleared 510(K)
- K083175BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 22Cleared 510(K)
- K083159BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 22Cleared 510(K)
- K082248STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER2Cleared 510(K)
- K082675STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER2Cleared 510(K)
- K071265SMARTCHECK INR SYSTEM2Cleared 510(K)
- K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP2Cleared 510(K)
- K060162ACL ELITE; ACL ELITE PRO2Cleared 510(K)
- K051030COAG-A-MATE MTX III2Cleared 510(K)
- K050053HEMORAM/AGGRAM ANALYZER2Cleared 510(K)
- K050243IMMEDIA PROTHROMBIN TIME SYSTEM2Cleared 510(K)
- K050513MDA B.302Cleared 510(K)
- K050016HEMOCHRON SIGNATURE ELITE2Cleared 510(K)
- K040359HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 22Cleared 510(K)
- K033137POTENS +2Cleared 510(K)
- K030818HEMOCHRON RESPONSE/SYSTEM2Cleared 510(K)
- K023141MODIFICATION TO STANDARD HUMAN PLASMA2Cleared 510(K)
- K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED2Cleared 510(K)
- K020798HEMOCHRON JR. SIGNATURE +2Cleared 510(K)
- K013114BCS SYSTEM2Cleared 510(K)
- K011665BCT SYSTEM2Cleared 510(K)
- K011235SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-15002Cleared 510(K)
- K010494SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-15002Cleared 510(K)
- K002080BEHRING COAGULATION SYSTEM, MODEL BCS2Cleared 510(K)
- K002177THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES2Cleared 510(K)
- K994349COAGUCHEK S SYSTEM, MODEL 21382802Cleared 510(K)
- K002400MODIFICATION OF ACL ADVANCE2Cleared 510(K)
- K001064BEHRING COAGULATION TIMER ANALYZER (BCT)2Cleared 510(K)
- K001067DADE BEHRING COAGULATION ANALYZER (BCT)2Cleared 510(K)
- K000973BEHRING COAGULATION SYSTEM (BCS)2Cleared 510(K)
- K993678THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES2Cleared 510(K)
- K000053ACL 9000 SYSTEM2Cleared 510(K)
- K992959BEHRING COAGULATION SYSTEM (BCS)2Cleared 510(K)
- K984501DADE BEHRING BFTII2Cleared 510(K)
- K990566TAS ANALYZER, MODEL 10092Cleared 510(K)
- K990449HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE2Cleared 510(K)
- K983892COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P2Cleared 510(K)
- K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZER2Cleared 510(K)
- K981711SYSMEX AUTOMATED COAGULATION ANALYZER CA-5002Cleared 510(K)
- K980839AVOCET PT2Cleared 510(K)
- K981815HEPTRAC ELECTRONIC QUALITY CONTROL2Cleared 510(K)
- K974799HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE2Cleared 510(K)
- K974569COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING2Cleared 510(K)
- K972260CS-400 COAGULATION ANALYZER SYSTEM (A1208)2Cleared 510(K)
- K970431BEHRING COAGULATION SYSTEM2Cleared 510(K)
- K964946SYSMEX CA-1000/SYSMEX CA-50002Cleared 510(K)
- K961908THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 14512Cleared 510(K)
- K960875KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)2Cleared 510(K)
- K954202PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS2Cleared 510(K)
- K955720AMAX CS-190 COAGULATION ANALYZER SYSTEM2Cleared 510(K)
- K955724KC 1A COAGULATION ANALYZER/SET2Cleared 510(K)
- K955735KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM2Cleared 510(K)
- K952625COAGUCHEK SYSTEM2Cleared 510(K)
- K951891ACL FUTURA COAGULATION SYSTEM2Cleared 510(K)
- K952560SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER2Cleared 510(K)
- K951497CASCASE 480 SNSLYZER2Cleared 510(K)
- K926551BEHRING FIBRINTIMER A2Cleared 510(K)
- K942096TOA MEDICAL ELECTRONICS CA-10002Cleared 510(K)
- K942097TOA MEDICAL ELECTRONICS CA-50002Cleared 510(K)
- K940957HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM2Cleared 510(K)
- K940840ACT CONTROL SET2Cleared 510(K)
- K940401JR. MICROCOAGULATION SYSTEM2Cleared 510(K)
- K933886TOA MEDICAL ELECTRONICS CA-50002Cleared 510(K)
- K934747R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 54702Cleared 510(K)
- K931149CA-1000 AUTOMATED COAGULATION ANALYZER2Cleared 510(K)
- K933188DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI2Cleared 510(K)
- K930068HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION2Cleared 510(K)
- K930454BOEHRINGER MANNHEIM COAGUCHEK SYSTEM2Cleared 510(K)
- K930849VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA2Cleared 510(K)
- K925340COAGULATION CONTROL CONTAINING HEMOGLOBIN2Cleared 510(K)
- K926222OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#53762Cleared 510(K)
- K923761ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM2Cleared 510(K)
- K924509CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION2Cleared 510(K)
- K924453MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)2Cleared 510(K)
- K924124BEHRING FIBRINTIMER A2Cleared 510(K)
- K924393STANDARD HUMAN PLASMA2Cleared 510(K)
- K914188KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM2Cleared 510(K)
- K912087ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS2Cleared 510(K)
- K912061HEPARIN ADSORBENT2Cleared 510(K)
- K902458ACS 0.02 M CALCIUM CHLORIDE2Cleared 510(K)
- K900917COAG-A-MATE - RA42Cleared 510(K)
- K900506MODIFIED COATRON II AND COATRON JR.2Cleared 510(K)
- K900377COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN2Cleared 510(K)
- K894466HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS2Cleared 510(K)
- K894359CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS2Cleared 510(K)
- K893650PLATELET AGGREGATION PROFILER MODEL PAP-4C2Cleared 510(K)
- K884534PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER2Cleared 510(K)
- K885076COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE2Cleared 510(K)
- K883689ORTHO OWREN'S BUFFER2Cleared 510(K)
- K883637KD 0.02 M CALCIUM CHLORIDE SOLUTION2Cleared 510(K)
- K883635KD 0.1 M SODIUM CITRATE SOLUTION2Cleared 510(K)
- K883640KD ONE-STAGE PROTHROMBIN TIME TEST2Cleared 510(K)
- K883484OWREN'S VERONAL BUFFER2Cleared 510(K)
- K882444COAG-I ANALYZER, ALPHA MODEL2Cleared 510(K)
- K881367ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS2Cleared 510(K)
- K880713CLP 0.1 M SODIUM CITRATE SOLUTION2Cleared 510(K)
- K875089HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN2Cleared 510(K)
- K872377CHROM-TROL2Cleared 510(K)
- K870831PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA2Cleared 510(K)
- K870771PT HEPARIN ADSORBENT2Cleared 510(K)
- K870687COAGULATION CONTROL, LEVEL III2Cleared 510(K)
- K870686COAGULATION CONTROL, LEVEL II2Cleared 510(K)
- K870685COAGULATION CONTROL, LEVEL I2Cleared 510(K)
- K870688O.O2 M CALCIUM CHLORIDE SOLUTION2Cleared 510(K)
- K870960COAG-A-MATE(R) XC2Cleared 510(K)
- K864534ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER2Cleared 510(K)
- K864532ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER2Cleared 510(K)
- K864271IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA2Cleared 510(K)
- K862537KOAGULAB* M COAGULATION SYSTEM2Cleared 510(K)
- K860719BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)2Cleared 510(K)
- K854938COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.2Cleared 510(K)
- K860342MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP2Cleared 510(K)
- K854546MICROSAMPLE COAGULATION ANALYSER MODEL 110P2Cleared 510(K)
- K854090DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT2Cleared 510(K)
- K854089DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT2Cleared 510(K)
- K854376HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS2Cleared 510(K)
- K853986THROMBOPLASTIN-R REAGENT2Cleared 510(K)
- K853328KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS2Cleared 510(K)
- K851153COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE2Cleared 510(K)
- K853789ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR2Cleared 510(K)
- K853198ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES2Cleared 510(K)
- K852450LODE COAGULOMETER MODEL LC-62Cleared 510(K)
- K853246CALCIUM CHLORIDE2Cleared 510(K)
- K853077CITREX II2Cleared 510(K)
- K853078CITREX III2Cleared 510(K)
- K853076CITREX I2Cleared 510(K)
- K851127DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO2Cleared 510(K)
- K850409GEN. DIAG. CHROMOSTRATE REF. PLASMA2Cleared 510(K)
- K842717COBAS-FIBRO2Cleared 510(K)
- K841523OWREN'S VERONAL BUFFERR2Cleared 510(K)
- K841462HEPARIN COAGULATION CONTROL PLASMA 1-2Cleared 510(K)
- K833272THROMBOPLASTIN - FS2Cleared 510(K)
- K832225ORTHO ABNORMAL COAGULATION LEVEL I/II2Cleared 510(K)
- K812121DIGICLOT 2-#8202Cleared 510(K)
- K812122MULTI CLOT-#8192Cleared 510(K)
- K812124MLA ELECTRA 7002Cleared 510(K)
- K792310NORM-TROL2Cleared 510(K)
- K791586ELVI 818 DIGICLOT MULTISCAN2Cleared 510(K)
- K790323COAG-A-MATE 20012Cleared 510(K)
- K790204PLASMA, STANDARDIZED NORMAL2Cleared 510(K)
- K780810MLA ELECTRA 750 COAGULATION TIMER2Cleared 510(K)
- K770606ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH2Cleared 510(K)
- K761091TPC-LYOPHILIZED POOLED HUMAN PLASMA2Cleared 510(K)
- K761176CALCIUM CHLORIDE (0.025M)2Cleared 510(K)
- K761175IMIDAZOLE BUFFER (0.05M)2Cleared 510(K)
- K761173TRIS BUFFERED2Cleared 510(K)
- K761172TRIS BUFFERED SALINE2Cleared 510(K)
- K761171VERONAL BUFFER2Cleared 510(K)
- K760594AUTO-FI COAGULATION INSTRUMENT2Cleared 510(K)
- JPJRed-Cell Indices, Calculated2Product Code
- JWODevice, Blood Volume Measuring2Product Code
- KQGInstrument, Coagulation2Product Code
- KQHRed-Cell Indices2Product Code
- LGPAssay, Alpha-2-Antiplasmin2Product Code
- LKMCounter, Urine Particle2Product Code
- LLGKit, Igg, Platelet Associated2Product Code
- MAMDna-Probe, B And T Lymphocyte2Product Code
- OBW11-Dehydro Thromboxane B2 Kit, Urinary2Product Code
- OYEFlow Cytometric Reagents And Accessories.2Product Code
- PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System2Product Code
- POVSemen Analysis Device2Product Code
- QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K021162
- 510(k) Type
- Traditional
- Applicant
- SIGMA DIAGNOSTICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/30/2002
- Days to Decision
- 141 days
- Submission Type
- Summary