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
- K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.01Cleared 510(K)
- K983468FASTTAKE ADAPTER, MODEL # P/N 020-072-011Cleared 510(K)
- K964460THE ROBOLITE1Cleared 510(K)
- K953652PRENVAL I1Cleared 510(K)
- K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)1Cleared 510(K)
- K923316EXPRESSO CARTRIDGE1Cleared 510(K)
- K893838MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K892060CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM1Cleared 510(K)
- K885292COBAS MFC1Cleared 510(K)
- K881194RIA-QUICK1Cleared 510(K)
- K871853V-MARC 88A COMPUTER1Cleared 510(K)
- K871339KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM1Cleared 510(K)
- K864557710 PLUS1Cleared 510(K)
- K861844GLUCOFACTS DATA MANAGEMENT SYSTEM1Cleared 510(K)
- K861779GLUCOFACTS DATA PRINTER1Cleared 510(K)
- K861778CLINIFACTS 200 DATA MANAGEMENT SYSTEM1Cleared 510(K)
- K861412DIRECT READOUT MODULE ACCESSORY1Cleared 510(K)
- K853026BIOVATION MAX DATA MANAGEMENT SYSTEM1Cleared 510(K)
- K851321ATAC 2000 CHEMISTRY ANALYZER1Cleared 510(K)
- K850659SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER1Cleared 510(K)
- K844907CLINIFACTS 10 DATA MANAGEMENT SYSTEM1Cleared 510(K)
- K843365ISO-DATA IMMUNOASSAY NETWORK SYSTEM1Cleared 510(K)
- K842401CHEMISTRY CONSOLE1Cleared 510(K)
- K831830LYRIS MODULAR INFO SYSTEM1Cleared 510(K)
- K834490GELSCAN SOFTWARE 21901Cleared 510(K)
- K840502CATS-CLINICAL LAB COMPUTER SOFTWARE-1Cleared 510(K)
- K834300HYBRITECH DATA STATION1Cleared 510(K)
- K831838LABORATORY DATA MGMT SYSTEM SDMS1Cleared 510(K)
- K833353ACLAIM-QAP IBM PERSONAL COMPUTER EDT1Cleared 510(K)
- K832746DUPONT LINEARIZATION MODULE1Cleared 510(K)
- K832760RIA SOFTWARE1Cleared 510(K)
- K831574BLOOD GAS QUALITY CONTROL SOFT-86000F1Cleared 510(K)
- K830296CORNING 102 PRINTER1Cleared 510(K)
- K823785API MDS*1Cleared 510(K)
- K823679NML 6000 CT1Cleared 510(K)
- K822778BLOOD GAS EXPER. SYSTEM 87001Cleared 510(K)
- K823110QAP MICROCOMPUTER SYSTEM1Cleared 510(K)
- K822932EMIT CLINICAL PROCESSOR #CP-50001Cleared 510(K)
- K822860RIA SSIST TI-59 MAGNETIC CARD PROGRAMS1Cleared 510(K)
- K822381SYVA LAB PROCESSOR 60001Cleared 510(K)
- K822146CORNING 101 PRINTER1Cleared 510(K)
- K821807AMERIFLOUR FLUOROMETER1Cleared 510(K)
- K821531EMIT TIMER UNIT #1001Cleared 510(K)
- K821058715 DELTA TERMINAL1Cleared 510(K)
- K820721COMPUTERIZED INTERPRETATION OF ARTERIAL1Cleared 510(K)
- K820427IL 8060 DATA MANAGEMENT SYSTEM1Cleared 510(K)
- K812604BIOVATION URINALYSIS REPORTER1Cleared 510(K)
- K810968BCD-HPP41C INTERFACE1Cleared 510(K)
- K810631DPM CALCULATOR1Cleared 510(K)
- K803312MICROMEDIC AUTOMATIC COMPUTING CENTER1Cleared 510(K)
- K810063AUTOMATIC BIOCHEMICAL ANALYZER1Cleared 510(K)
- K802594BECKMAN DP-5500 DATA REDUCTION SYSTEM1Cleared 510(K)
- K802471CHEMTROLER1Cleared 510(K)
- K802251SP 120 SOPHISTICATE1Cleared 510(K)
- K801664SERALYZER GLUCOSE TEST MODULE1Cleared 510(K)
- K801438CENTRIFICHEM SYSTEM MANAGER1Cleared 510(K)
- K801210BIOSTATOR PRINTER/PLOTTER1Cleared 510(K)
- K801167CENTRIFICHEM SYSTEM 4001Cleared 510(K)
- K801091K 750 COMPUTER/DATA PROCESSOR1Cleared 510(K)
- K801131IL88640 & 88641 CASSETTE-TAPE PROGRAM1Cleared 510(K)
- K800724AMES LAB MANAGEMENT SYSTEM1Cleared 510(K)
- K800282DATA MANAGEMENT SYSTEM IL MODEL 7751Cleared 510(K)
- K800242MICRO MEDICAL DATA SYSTEM II1Cleared 510(K)
- K800241MICRO MEDICAL DATA SYSTEM1Cleared 510(K)
- K7921583388 REPORTING INTEGRATOR1Cleared 510(K)
- K792129EMIT CLINICAL PROCESSOR-CP 50001Cleared 510(K)
- K790543THE ABBOTT EXECUTIVE1Cleared 510(K)
- K790336UNION CARBIDE CORP. COMPUTER INTERFACE1Cleared 510(K)
- K782052PROCESSOR, K750 COMPUTER/DATA1Cleared 510(K)
- K781081EMIT MCA PROGRAM TAPE1Cleared 510(K)
- K781173COMPUTER INTERFACE IL 8141Cleared 510(K)
- K781217DATA TERMINAL MODEL 7221Cleared 510(K)
- K780881EMIT CLINICAL PROCESSOR - CP 50001Cleared 510(K)
- K770877DATA REDUCTION SYSTEM, DP-30001Cleared 510(K)
- K770671CALCULATOR, ENZYME, TURNER1Cleared 510(K)
- K761063GAMMACORD II CALCULATOR INTERFACE1Cleared 510(K)
- K760739ACA DATA MATE ACCESSORY1Cleared 510(K)
- 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
CHEMISTRY CONSOLE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K842401
- 510(k) Type
- Traditional
- Applicant
- BIOVATION, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/4/1984
- Days to Decision
- 77 days