Anesthesiology
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- 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)
Show All 77 Submissions
- 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
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BIONIME DIABETES MANAGEMENT SYSTEM VI.0
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K113007
- 510(k) Type
- Traditional
- Applicant
- BIONIME CORPORATION
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/27/2012
- Days to Decision
- 143 days
- Submission Type
- Summary