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
- 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
- GIRReagent, Russel Viper Venom1Product Code
- GJNFluid, Diluting, Red-Cell1Product Code
- GJPControl, Platelet2Product Code
- GJRControl, Red-Cell2Product Code
- GFSStandards And Controls, Hemoglobin, Normal And Abnormal2Product Code
- GGJFluid, Diluting, White-Cell1Product Code
- GGKProducts, Red-Cell Lysing Products1Product Code
- GGLControl, White-Cell2Product Code
- GGMControl, Hemoglobin2Product Code
- GIFDiluent, Blood Cell1Product Code
- GLKControl, Hematocrit2Product Code
- GLQMixture, Control, White-Cell And Red-Cell Indices2Product Code
- JCFLymphocyte Separation Medium1Product Code
- JCGFluid, Diluting, Manual Cell1Product Code
- JCNControl, Cell Counter, Normal And Abnormal2Product Code
- JCOBothrops Atrox Reagent2Product Code
- JPKMixture, Hematology Quality Control2Product Code
- K160588XN CHECK BF2Cleared 510(K)
- K160586XN-L CHECK2Cleared 510(K)
- K160590XN CHECK2Cleared 510(K)
- K160606BC-5D Hematology Control2Cleared 510(K)
- K141957XN CHECK BF2Cleared 510(K)
- K141964XN CHECK2Cleared 510(K)
- K130962R&D 5D RETIC HEMATOLOGY CONTROL2Cleared 510(K)
- K120742XN CHECK2Cleared 510(K)
- K120744XN CHECK BF2Cleared 510(K)
- K101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL2Cleared 510(K)
- K100790COULTER LIN-X LINEARITY CONTROL, MODEL A811962Cleared 510(K)
- K100607COULTER 4C-EX 300 CELL CONTROL2Cleared 510(K)
- K091303LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV2Cleared 510(K)
- K100050R & D SYSTEMS XERET HEMATOLOGY CONTROL2Cleared 510(K)
- K091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL2Cleared 510(K)
- K090201UA-CELLULAR FOR IQ2Cleared 510(K)
- K082162COULTER BODY FLUID CONTROL2Cleared 510(K)
- K081822COULTER 6C CELL CONTROL, MODELS 628027 & A599252Cleared 510(K)
- K081641COULTER LIN-X LINEARITY CONTROL2Cleared 510(K)
- K073178HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT0042Cleared 510(K)
- K072846CSF AUTOMATED CONTROL, MODELS CSF001, CSF0032Cleared 510(K)
- K072268HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S2Cleared 510(K)
- K072096CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR042Cleared 510(K)
- K070199RETIC-CHEX LINEARITY FOR BC2Cleared 510(K)
- K063218E-CHECK (XE)2Cleared 510(K)
- K061511R&D CBC-3D + CRP HEMATOLOGY CONTROL2Cleared 510(K)
- K061320R&D LH-NRBC HEMATOLOGY CONTROL2Cleared 510(K)
- K061064COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 7235032Cleared 510(K)
- K060464COULTER 5C CELL CONTROL2Cleared 510(K)
- K053362CELL-CHEX AUTO2Cleared 510(K)
- K051706IQ BODY FLUIDS CONTROL2Cleared 510(K)
- K051339R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL2Cleared 510(K)
- K050721ABX ERYTROL2Cleared 510(K)
- K042836LIQUICHEK RETICULOCYTE CONTROL (A)2Cleared 510(K)
- K042587RETIC-CHEX FOR CELL-DYN2Cleared 510(K)
- K042336METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK2Cleared 510(K)
- K042094R&D CBC-XE HEMATOLOGY CONTROL2Cleared 510(K)
- K041457LIQUICHEK HEMATOLOGY CONTROL (A)2Cleared 510(K)
- K024173CDS 3-PD HEMATOLOGY CONTROLS2Cleared 510(K)
- K022968ADVIA TESTPOINT CSF CONTROL2Cleared 510(K)
- K021922MODIFICATION TO PARA 5X2Cleared 510(K)
- K020229R & D BODY FLUID CONTROL2Cleared 510(K)
- K013898R&D RET-LINE KIT2Cleared 510(K)
- K013842IMMUNO-TROL LOW CELLS2Cleared 510(K)
- K011410PARA 5X2Cleared 510(K)
- K010470R & D 4K RETIC2Cleared 510(K)
- K010461ADVIA RETIC PLUS2Cleared 510(K)
- K010598SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL2Cleared 510(K)
- K010409CBC-SF2Cleared 510(K)
- K0100665C-ES CELL CONTROL, MODELS 7547191, 75471922Cleared 510(K)
- K0100644C-ES CELL, MODELS 7547187, 7547188, 7547189, 75471902Cleared 510(K)
- K003874CBC-4K HEMATOLOGY CONTROL2Cleared 510(K)
- K003534PENTRA 5D2Cleared 510(K)
- K003208R & D 3K RETIC2Cleared 510(K)
- K002511FETALTROL2Cleared 510(K)
- K000115RETIC CHEX LINEARITY2Cleared 510(K)
- K993496RETIC-QUINOX2Cleared 510(K)
- K991876SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE2Cleared 510(K)
- K984216IMMUNO-TROL CONTROL CELLS2Cleared 510(K)
- K983032CBC-5D HEMATOLOGY CONTROL2Cleared 510(K)
- K984099QBC CENTRIFUGAL HEMATOLOGY CONTROL2Cleared 510(K)
- K972172ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION2Cleared 510(K)
- K972170ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION2Cleared 510(K)
- K971469COULTER ACT TRON CELL CONTROL2Cleared 510(K)
- K970331CBC-4K HEMATOLOGY CONTROL2Cleared 510(K)
- K961673R&D RETIC-PG HEMATOLOGY CONTROL2Cleared 510(K)
- K960557CALIBRATION VERIFICATION ASSESSMENT (CVA)2Cleared 510(K)
- K960471TRI-COUNT 202Cleared 510(K)
- K960005TRI-COURT 20-T2Cleared 510(K)
- K955334COULTER LINEARITY CONTROL2Cleared 510(K)
- K9550164C PLUS COULTER CELL CONTROL2Cleared 510(K)
- K954137QBC CENTRIFUGAL HEMATOLOGY CONTROL2Cleared 510(K)
- K952720AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II2Cleared 510(K)
- K952245SF-CHECK2Cleared 510(K)
- K941965EZ-RANGE2Cleared 510(K)
- K943336RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE2Cleared 510(K)
- K943335RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE2Cleared 510(K)
- K944751COULTER FLOW SET2Cleared 510(K)
- K942822CBC-LINE HEMATOLOGY LINEARITY CONTROL2Cleared 510(K)
- K935196PARA 5 DIFF2Cleared 510(K)
- K940089CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE2Cleared 510(K)
- K940181SE-CHECK2Cleared 510(K)
- K935343CENTRIFIQ BLOOD CONTROL2Cleared 510(K)
- K931947CHECKPOINT2Cleared 510(K)
- K930119COULTER RETIC-C CELL CONTROL2Cleared 510(K)
- K923971QC-CHEX2Cleared 510(K)
- K914099GAS TRAK CONNECT BLOOD GAS CONTROL2Cleared 510(K)
- K913879CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE2Cleared 510(K)
- K912133PX COULTER(R) CELL CONTROL2Cleared 510(K)
- K905524RETIC-CHEX2Cleared 510(K)
- K904637QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE2Cleared 510(K)
- K904461METER TRAX2Cleared 510(K)
- K904464CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED2Cleared 510(K)
- K900017REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)2Cleared 510(K)
- K893895HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL2Cleared 510(K)
- K884266PH BLOOD GAS CONTROL PRODUCTS2Cleared 510(K)
- K890767NE-CHECK2Cleared 510(K)
- K890749CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE2Cleared 510(K)
- K880270MSI-DIFF PLUS2Cleared 510(K)
- K873354QBC VENOUS BLOOD CONTROL/MULTIPLE2Cleared 510(K)
- K871067MSI HEMATOLOGY CONTROL +2Cleared 510(K)
- K863224HEMATALL-C PLUS HEMATOLOGY CONTROLS2Cleared 510(K)
- K862318FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR2Cleared 510(K)
- K862186LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II2Cleared 510(K)
- K860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA2Cleared 510(K)
- K854353PLATELET-TROL II2Cleared 510(K)
- K852992PARA CHECK (AKA EIGHT CHECK-C)2Cleared 510(K)
- K853776MSI-HB HEMOGLOBIN CONTROL2Cleared 510(K)
- K852372CELL-DYN BRAND HEMATOLOGY REAGENTS2Cleared 510(K)
- K851663QUICK-COUNT HEMATOLOGY CONTROLS2Cleared 510(K)
- K851375TRI-COUNT2Cleared 510(K)
- K850755CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL2Cleared 510(K)
- K850250TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH2Cleared 510(K)
- K844927QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS2Cleared 510(K)
- K844928QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE2Cleared 510(K)
- K844897HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 82Cleared 510(K)
- K843805COULTER CHECK SAMPLE UNASSAYED HEMATOLOG2Cleared 510(K)
- K843485TRI-COUNT LASER2Cleared 510(K)
- K841809COUNT-A-PART PLUS2Cleared 510(K)
- K843962CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE2Cleared 510(K)
- K843093RETIC-CHEX2Cleared 510(K)
- K842286DIA T1, T2 & T32Cleared 510(K)
- K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH2Cleared 510(K)
- K842109TECHNICON TEST POINT ASSAYED HEMATOLOGY2Cleared 510(K)
- K841531PARA-TEK2Cleared 510(K)
- K842017PARA 42Cleared 510(K)
- K841239ASSIGNED VALUE FOR MEAN PLATELET2Cleared 510(K)
- K840302PLT - 4 PLATELET2Cleared 510(K)
- K834371TRI-COUNT 102Cleared 510(K)
- K834043MSI-HC HEMATOLOGY CONTROL2Cleared 510(K)
- K833563HC PLUS2Cleared 510(K)
- K833130TRI-COUNT 72Cleared 510(K)
- K831704TECHNICON H6000 SYSTEM CONTROL2Cleared 510(K)
- K830864WHITE BLOOD CELL CONTROL2Cleared 510(K)
- K831094PARA LASAR2Cleared 510(K)
- K820731HEMATALL-C PLUS HEMATOLOGY CONTROLS2Cleared 510(K)
- K820401ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW2Cleared 510(K)
- K820400ORTHO* HEMATOLOGY CONTROL 8 NORMAL2Cleared 510(K)
- K812280HEMATOLOGY CONTROL2Cleared 510(K)
- K812237HEMOTOLOGY QUALITY CONTROL MIXTURE2Cleared 510(K)
- K812357VENTREX DATA REDUCTION & QUAL. CONTR. SY2Cleared 510(K)
- K810756HEMOTOLOGY QUALITY CONTROL MIXTURES2Cleared 510(K)
- K801054THROMBO-TEST (X)2Cleared 510(K)
- K803083ORTHO HEMOTOLOGY CONTROL-NORMAL2Cleared 510(K)
- K803084ORTHO HEMATOLOGY CONTROL ABNORMAL LOW2Cleared 510(K)
- K803073ORTHO HEMATOLOGY CONTROL2Cleared 510(K)
- K802267PLT-4 SIZE-CHECK2Cleared 510(K)
- K802265CBC PLT-42Cleared 510(K)
- K802142CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL2Cleared 510(K)
- K802143CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET2Cleared 510(K)
- K802141CH-60 PLUS WHOLE BLOOD PLATELET CONTROL2Cleared 510(K)
- K801267RED BLOOD CELL COUNT & HEMATOCRIT CNTL2Cleared 510(K)
- K801265WHITE BLOOD CELL COUNT CONTROL LEVELS2Cleared 510(K)
- K800938TRI-CHECK2Cleared 510(K)
- K800780SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS2Cleared 510(K)
- K800361HEMATO-CHEX2Cleared 510(K)
- K792606WHOLE BLOOD PLATELET CONTROL NORMAL,2Cleared 510(K)
- K792467PLATELET-CHEX FOR BLOOD CENTERS2Cleared 510(K)
- K792209SANDARE HEMOGLOBIN CONTROLS2Cleared 510(K)
- K792055FISHER DIAGNOSTICS HEMATOLOGY CONTROLS2Cleared 510(K)
- K791772COUNTER-CHECK PLUS NORMAL, HIGH ABN.2Cleared 510(K)
- K791750COUNTER-CHECK PLUS2Cleared 510(K)
- K791226PLATELET-CHEX PLUS2Cleared 510(K)
- K791228PARA-82Cleared 510(K)
- K791227PARA-72Cleared 510(K)
- K791030HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL2Cleared 510(K)
- K790826COAGULATION ARP2Cleared 510(K)
- K790457HEMOGLOBIN CONTROLS2Cleared 510(K)
- K790415HCP-72Cleared 510(K)
- K790525HEMATROL S HEMATOLOGY CONTROLS2Cleared 510(K)
- K781969BLOOD, HEMATOLOGY REFERENCE CONTROL2Cleared 510(K)
- K781745QUANTICEL HHR, L531 AND L5322Cleared 510(K)
- K781786QUANTICEL HHR # L500 AND L5012Cleared 510(K)
- K781573ABNORMAL HEMATOLOGY CONTROL UNASSAYED2Cleared 510(K)
- K781572NORMAL HEMATOLOGY CONTROL UNASSAYED2Cleared 510(K)
- K781247QUANTICEL-HRP2Cleared 510(K)
- K781077CONTROL, HEMATOLOGY, CH-602Cleared 510(K)
- K780980PLATELET CONTROL2Cleared 510(K)
- K780835ARANTROL2Cleared 510(K)
- K780714PLATELET CONTROL2Cleared 510(K)
- K780140CELL-CHEX2Cleared 510(K)
- K772195HEMATOLOGY REFERENCE CONTROLS2Cleared 510(K)
- K771753HEMATOLOGY REFERENCE CONTROL2Cleared 510(K)
- K770384MNITROL HEMOTOL. REF. AND CONTROL2Cleared 510(K)
- K770386LATELET, CONTROL, NORMAL & ABNORMAL2Cleared 510(K)
- K770095PLATELET CONTROL, NORMAL & ABNORMAL2Cleared 510(K)
- K770020PLATELET-CHEX-HUMAN2Cleared 510(K)
- K7606824C ABNORMAL LOW-HIGH (8 X 6 M1)2Cleared 510(K)
- K760597BIOTROL-NORMAL2Cleared 510(K)
- K760596BIOTROL-ABNORMAL2Cleared 510(K)
- K760549PLATELET CONTROLS, NORMAL & ABNORMAL2Cleared 510(K)
- K760162HEMATOLOGY CONTROL2Cleared 510(K)
- KRXCalibrator For Cell Indices2Product Code
- KRYCalibrator For Platelet Counting2Product Code
- KRZCalibrator For Hemoglobin And Hematocrit Measurement2Product Code
- KSACalibrator For Red-Cell And White-Cell Counting2Product Code
- MZGTest, Residual, Wbc In Leukoreduced Blood2Product Code
- NRFMaterial, Quality Control, Semen Analysis2Product Code
- NRSControl Material, Blood Circulating Epithelial Cancer Cell2Product Code
- 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
ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K820401
- 510(k) Type
- Traditional
- Applicant
- ORHTO DIAGNOSTIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/15/1982
- Days to Decision
- 31 days