Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- GLEMixer, Blood Tube1Product Code
- JBSTimer, General Laboratory1Product Code
- JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use1Product Code
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use1Product Code
- JJFAnalyzer, Chemistry, Micro, For Clinical Use1Product Code
- JJGAnalyzer, Chemistry, Centrifugal, For Clinical Use1Product Code
- JJHClinical Sample Concentrator1Product Code
- JJIAnalyzer, Enzyme, For Clinical Use1Product Code
- JJJCounter (Beta, Gamma) For Clinical Use1Product Code
- JJKOncometer, Plasma, For Clinical Use1Product Code
- JJLPlasma Viscometer For Clinical Use1Product Code
- JJMOsmometer For Clinical Use1Product Code
- JJNApparatus, Electrophoresis, For Clinical Use1Product Code
- JJOFlame Emission Photometer For Clinical Use1Product Code
- JJPElectrode, Ion Selective (Non-Specified)1Product Code
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use1Product Code
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use1Product Code
- JQOBalance, Analytical1Product Code
- JQPCalculator/Data Processing Module, For Clinical Use1Product Code
- JQQDialyzer1Product Code
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica1Product Code
- JQWStation, Pipetting And Diluting, For Clinical Use1Product Code
- JQXNephelometer, For Clinical Use1Product Code
- JQYPh Meter1Product Code
- JQZPolarimeter1Product Code
- JRAMicrotitrator, For Clinical Use1Product Code
- JRBMicro Mixer1Product Code
- JRCMicro Pipette1Product Code
- JRERefractometer For Clinical Use1Product Code
- JRGBlock, Heating1Product Code
- JRICuvette, Thermostated1Product Code
- JRJUnit, Drying1Product Code
- JRKEvaporator1Product Code
- JRLUnit, Filter, Membrane1Product Code
- JRMFreezer1Product Code
- JROBlender/Mixer1Product Code
- JRQShaker/Stirrer1Product Code
- JRRRegulator, Temperature1Product Code
- JRSPurifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)1Product Code
- KHOFluorometer, For Clinical Use1Product Code
- K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..1Cleared 510(K)
- K973547TRIAGE STATMETER1Cleared 510(K)
- K971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM1Cleared 510(K)
- K962919VITROS IMMUNODIAGNOSTIC SYSTEM1Cleared 510(K)
- K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)1Cleared 510(K)
- K950415FLUOROSCAN NEONATAL1Cleared 510(K)
- K935047AUTO DELFIA1Cleared 510(K)
- K930689AUTOBEAD THYROID UPTAKE1Cleared 510(K)
- K926131OPUS MAGNUM ANALYZER1Cleared 510(K)
- K923021AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM1Cleared 510(K)
- K920888MICROLITE MICROTITER PLATE LUMINOMETER ML22001Cleared 510(K)
- K913130STRATUS IINTELLECT IMMUNOASSAY SYSTEM1Cleared 510(K)
- K901674AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM1Cleared 510(K)
- K895240DELFIA PLATE FLUOROMETER 12321Cleared 510(K)
- K894159OPUS IMMUNOASSAY SYSTEM1Cleared 510(K)
- K890908STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES1Cleared 510(K)
- K872803CYBERFLUOR 615 IMMUNOANALYZER1Cleared 510(K)
- K871550PFI-20 POLARIZING FLUORIMETER1Cleared 510(K)
- K860309HEMAFLUOR REAGENT KIT1Cleared 510(K)
- K851984LKB-WALLAC 1230 ARCUS FLUOROMETER1Cleared 510(K)
- K830624FLUOROMETER, GENERAL USE1Cleared 510(K)
- K822942INNOTRON FLUORIMETER SERIES ONE-101Cleared 510(K)
- K823112CLINISTAT TDA SERIES1Cleared 510(K)
- K822772MICROFLUOR READER1Cleared 510(K)
- K822701FLUOROSTAT FLUOROMETER1Cleared 510(K)
- K813540A FLUOROMETER1Cleared 510(K)
- K813146SYVA ADVANCE TM FLUOROMETER1Cleared 510(K)
- K811019LKB 4460 FLUORIMETER1Cleared 510(K)
- K802579CYBREX TM FPQ FLUORESCENE POLARIZATION1Cleared 510(K)
- K791329FLUOROMATIC ANALYZER AND AUTOSAMPLER1Cleared 510(K)
- K790236SPECTROPHOTOMETER MODEL 650-401Cleared 510(K)
- K790235SPECTROPHOTOMETER MODEL 30001Cleared 510(K)
- K780242SPECTROPHOTOMETER, FLUORESCENCE M.650-101Cleared 510(K)
- K780362SPECTROFLUOROMETER SF-3301Cleared 510(K)
- K780122HTSH RIA1Cleared 510(K)
- K780031FLUORESCENCE DETECTOR MODEL 4201Cleared 510(K)
- K760506HEMAFLOUR ZP1Cleared 510(K)
- K760261DETECTOR, MODEL LC-100 FLUORESCENCE1Cleared 510(K)
- KQOAutomated Urinalysis System1Product Code
- LCIAutomated Radioimmunoassay Systems, For Clinical Use1Product Code
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use1Product Code
- NSUInstrumentation For Clinical Multiplex Test Systems2Product Code
- NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System1Product Code
- OOIReal Time Nucleic Acid Amplification System2Product Code
- OTAMass Spectrometer For Clinical Multiplex Test Systems2Product Code
- OULThermocycler, Generic1Product Code
- OVAComplete Gene Expression Profiling Accessory Reagents2Product Code
- PCADna Genetic Analyzer2Product Code
- PEGNucleic Acid Quantitation Kit1Product Code
- PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis1Product Code
- PHGDroplet Digital Pcr System2Product Code
- PHVContinuous Glucose Monitor Retrospective Data Analysis Software1Product Code
- PSMRefractometer For Donor Testing1Product Code
- QBZAutomated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma1Product Code
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- 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
HEMAFLUOR REAGENT KIT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K860309
- 510(k) Type
- Traditional
- Applicant
- HELENA LABORATORIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/14/1986
- Days to Decision
- 167 days