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
- K924021POWER SUPPLY1Cleared 510(K)
- K924020ELECTROPHORESIS TANK1Cleared 510(K)
- K882344ELECTR-TRANSBLOTTER1Cleared 510(K)
- K881852REP SP ELECTROPHORESIS SYSTEM CAT NO. 31701Cleared 510(K)
- K882163HELENA REP GEL PROCESSOR1Cleared 510(K)
- K873352RAPID ELECTROPHORESIS SYSTEM (REP)1Cleared 510(K)
- K864436STAVIP 30001Cleared 510(K)
- K861414ELECTROPHORESIS WORK CENTER (EWC)1Cleared 510(K)
- K841407ISOGEL AGAROSE1Cleared 510(K)
- K844710EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD1Cleared 510(K)
- K842560OPTIPHOR-101Cleared 510(K)
- K842485OPTICLEAR1Cleared 510(K)
- K841804ELVI 70 SAFETY CHAMBER1Cleared 510(K)
- K841288ELVI 181Cleared 510(K)
- K830797IMMOBILINE SYSTEM LKB 18191Cleared 510(K)
- K823132SARTOPHOR SYSTEM FOR ELECTROPHORESIS1Cleared 510(K)
- K822285CELLULOSE ACETATE MEMBRANE STRIPS1Cleared 510(K)
- K821688TITAN GEL HIGH RESOLUTION SERUM PROTEIN1Cleared 510(K)
- K821517TITANAN GEL SERUM PROTEIN ELECTROPHORES1Cleared 510(K)
- K821303HI-PHORE HIGH RESOLUTION ELECTROPHORES1Cleared 510(K)
- K803281AUTOMATED ELECTROPHORESIS SYSTEM1Cleared 510(K)
- K802396GENERAL PROCEDURE AGAROSE FILM1Cleared 510(K)
- K802395SPECIAL PROCEDURE AQAROSE FILM1Cleared 510(K)
- K801893CORNING 60 VOLT POWER SUPPLY1Cleared 510(K)
- K801378HIPP BUFFER(NON-BARBITAL), P/N1Cleared 510(K)
- K792553AGAROSE BARBITAL-EDTA BUFFER1Cleared 510(K)
- K792547AGAROSE BARBITAL BUFFER1Cleared 510(K)
- K791144BUFFERIZER1Cleared 510(K)
- K791111AUTOMATED ELECTROPHORESES MACHINE1Cleared 510(K)
- K772176CYSTIC FIBROSIS TESTING INSTRUMENT1Cleared 510(K)
- K771322ELECTROPHORESIS POWER SUPPLY TESTER1Cleared 510(K)
- K771323ELECTROPHORESIS OVEN THERMOMETER1Cleared 510(K)
- K761248ELECTROPHORESIS ACCESSORY MO. 35261Cleared 510(K)
- K760131AGARO-GEL, PRODUCT # A12661Cleared 510(K)
- 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
- 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
BUFFERIZER
- Page Type
- Cleared 510(K)
- 510(k) Number
- K791144
- 510(k) Type
- Traditional
- Applicant
- HELENA LABORATORIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/3/1979
- Days to Decision
- 46 days