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
- K170864VALIDATE D-Dimer Calibration Verification / Linearity Test Kit2Cleared 510(K)
- K163498VALIDATE Heparin Calibration Verification/Linearity Test Kit2Cleared 510(K)
- K161316George King Coumadin Plasma2Cleared 510(K)
- K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit2Cleared 510(K)
- K152961VALIDATE D-Dimer Calibration Verification/Linearity Test Kit2Cleared 510(K)
- K150144VisuCon-F Low Fibrinogen Control Plasma2Cleared 510(K)
- K142132POOL NORM2Cleared 510(K)
- K133582HEMOSIL D-DIMER HS 500 CONTROL2Cleared 510(K)
- K120977DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC2Cleared 510(K)
- K120900I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 22Cleared 510(K)
- K120014STA- COAG CONTROL (N+ABN) PLUS2Cleared 510(K)
- K113211HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL2Cleared 510(K)
- K110432VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN2Cleared 510(K)
- K100716AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-52Cleared 510(K)
- K093848PT-MULTI-CALIBRATOR, MODEL OPAT072Cleared 510(K)
- K103314CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL2Cleared 510(K)
- K103313HEPARIN ASSAY CONTROLS2Cleared 510(K)
- K091284VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA2Cleared 510(K)
- K090563HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)2Cleared 510(K)
- K082859HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED2Cleared 510(K)
- K071319I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-022Cleared 510(K)
- K062840TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS2Cleared 510(K)
- K063823COAGUCHEK XS PT CONTROLS2Cleared 510(K)
- K052697HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL2Cleared 510(K)
- K051472BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR2Cleared 510(K)
- K050799TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS2Cleared 510(K)
- K043451BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR2Cleared 510(K)
- K042760PEFAKIT APC-R FACTOR V LEIDEN CONTROLS2Cleared 510(K)
- K042333CONTROL PLASMA N, PROC CONTROL PLASMA2Cleared 510(K)
- K042209CONTROL PLASMA N AND CONTROL PLASMA P2Cleared 510(K)
- K042206PURPLE/BLACK HEPARIN ASSAY CONTROL2Cleared 510(K)
- K042175HEPARINASE HR ACT CONTROL, MODEL 550-122Cleared 510(K)
- K040275LYPHOCHEK HEMOSTASIS CONTROL2Cleared 510(K)
- K032611LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 7432Cleared 510(K)
- K032017LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 32Cleared 510(K)
- K030965CONTROL PLASMA LMW HEPARIN2Cleared 510(K)
- K030182LIQUICHEK D-DIMER CONTROL, MODEL 356, 3572Cleared 510(K)
- K022046VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL2Cleared 510(K)
- K021024HEMOSIL HIGH ABNORMAL CONTROL ASSAYED2Cleared 510(K)
- K021022HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)2Cleared 510(K)
- K021023HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)2Cleared 510(K)
- K012722LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,7832Cleared 510(K)
- K010750PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 1005602Cleared 510(K)
- K010350STA -CALIBRATOR HBPM/LMWH KIT2Cleared 510(K)
- K010324STA-QUALITY HBPM/LMWH KIT2Cleared 510(K)
- K000679THROMBOSTRATE CONTROL PLASMAS2Cleared 510(K)
- K994159HMP CONTROLS (TAS) RAPIDPOINT2Cleared 510(K)
- K991439POLLER CALIBRANTS2Cleared 510(K)
- K992829CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 32Cleared 510(K)
- K992278HEPARIN CONTROL PLASMA LEVEL 12Cleared 510(K)
- K992279HEPARIN CONTROL PLASMA LEVEL 22Cleared 510(K)
- K990858LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 7892Cleared 510(K)
- K981752I-STAT COAGULATION CONTROL SET2Cleared 510(K)
- K981255SIGMA DIAGNOSTICS ACCUCLOT CONTROL III2Cleared 510(K)
- K981254SIGMA DIAGNOSTICS ACCUCLOT CONTROL II2Cleared 510(K)
- K981248SIGMA DIAGNOSTICS ACCUCLOT CONTROL I2Cleared 510(K)
- K981178THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS2Cleared 510(K)
- K980982AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 22Cleared 510(K)
- K971219CRYO CHECK INR VALIDATION SET2Cleared 510(K)
- K971222CRYO CHECK APC RESISTANT PLASMA2Cleared 510(K)
- K964716STA LIATEST CONTROL [N]+[P] KIT2Cleared 510(K)
- K971428COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 02Cleared 510(K)
- K971748TAS PT-NCTEST CONTROLS2Cleared 510(K)
- K964963LYPHOCHEK COAGULATION CONTROL2Cleared 510(K)
- K962674STA - VWF CONTROL [N]+[P] KIT2Cleared 510(K)
- K961189TAS A PTT TEST CONTROLS2Cleared 510(K)
- K960234TAS HMT CONTROLS2Cleared 510(K)
- K955278BEHRING COAGULATION TIMER2Cleared 510(K)
- K952321PORCINE FACTOR VIII;C REAGENT2Cleared 510(K)
- K951823CRYO CHECK LOW FIBRINOGEN CONTROL2Cleared 510(K)
- K952622CRYO CHECK NORMAL HUMAN REFERENCE PLASMA2Cleared 510(K)
- K945855A-FACT, ABNORMAL FACTOR ASSAY CONTROL2Cleared 510(K)
- K945854B-FACT, BORDERLINE FACTOR ASSAY CONTROL2Cleared 510(K)
- K940209ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL2Cleared 510(K)
- K943518STA SYSTEM CONTROL [N] + [P] KIT2Cleared 510(K)
- K944691ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II2Cleared 510(K)
- K941860SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)2Cleared 510(K)
- K933277COAGULATION A.R.P.2Cleared 510(K)
- K922887CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM2Cleared 510(K)
- K924404CLIBRATION PLASMAS2Cleared 510(K)
- K922174COAG-CONTROL [N] KIT2Cleared 510(K)
- K921344THROMBO-CALIBRATOR KIT2Cleared 510(K)
- K914949COAGULATION ARPR,CAT.NO.51852Cleared 510(K)
- K911777ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED2Cleared 510(K)
- K905673AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 51832Cleared 510(K)
- K902363COAGULATION CONTROL, LEVEL III2Cleared 510(K)
- K902362COAGULATION CONTROL, LEVEL II2Cleared 510(K)
- K902361COAGULATION CONTROL, LEVEL I2Cleared 510(K)
- K902210ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA2Cleared 510(K)
- K900019ROCKET REFERENCE PLASMA, CAT NO. 51882Cleared 510(K)
- K884901DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO2Cleared 510(K)
- K884854COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)2Cleared 510(K)
- K882481HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II2Cleared 510(K)
- K882480HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II2Cleared 510(K)
- K881348VERIFY(R) REFERENCE PLASMA2Cleared 510(K)
- K880302CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER2Cleared 510(K)
- K840288DIACELIN2Cleared 510(K)
- K834086CONTACT-K APTT REAGENT2Cleared 510(K)
- K771346CI-TROL COAGULATION CONTROLS II & III2Cleared 510(K)
- 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
- 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
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
- Page Type
- Cleared 510(K)
- 510(k) Number
- K911777
- 510(k) Type
- Traditional
- Applicant
- HELENA LABORATORIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/22/1991
- Days to Decision
- 142 days