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
- K962762SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR1Cleared 510(K)
- K946387CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER1Cleared 510(K)
- K920559ABBOTT VERTEX ANALYZER1Cleared 510(K)
- K900087GENESYS 6000 GAMMA COUNTER1Cleared 510(K)
- K896202MATRIX(TM)-961Cleared 510(K)
- K894902SOURCERER1Cleared 510(K)
- K884091SOURCERER1Cleared 510(K)
- K884269SAMPLE IDENTIFICATION STATION MODEL 380101Cleared 510(K)
- K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTER1Cleared 510(K)
- K872429ISO-DATA 100 SERIES GAMMA COUNTER1Cleared 510(K)
- K872429ISO-DATA 100 SERIES GAMMA COUNTER1Cleared 510(K)
- K870115BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS1Cleared 510(K)
- K862206TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER1Cleared 510(K)
- K851164DENTOCULT CULTURE-PADDLE1Cleared 510(K)
- K851689GENESYS GAMMA COUNTER1Cleared 510(K)
- K8524341208 BETACORD AND 1208 BETCORD M1Cleared 510(K)
- K842902MICROSTAT GAMMA COUNTER1Cleared 510(K)
- K841352ND1200 RIA COUNTER1Cleared 510(K)
- K834508CORNING 4000 MULTI-WELL GAMMA COUNTER1Cleared 510(K)
- K832734KEMTEK 400 RIA GAMMA COUNTER1Cleared 510(K)
- K832736KEMTEK 104 RIA GAMMA COUNTER1Cleared 510(K)
- K832735KEMTEK 103 RIA GAMMA COUNTER1Cleared 510(K)
- K832210GAMMA PHOTON GAMMA COUNTER1Cleared 510(K)
- K832209KINETI COUNT 24 GAMMA COUNTER1Cleared 510(K)
- K832002NML-5010/5020 MULTI-DETECTOR SYSTEM1Cleared 510(K)
- K830751KEMTEK 1021Cleared 510(K)
- K830365KINETI COUNT 48 IMMUNOASSAY SYSTEM1Cleared 510(K)
- K823240CAP-RIA 161Cleared 510(K)
- K822293IMMU-COUNT 4041Cleared 510(K)
- K821892PHILLIPS RADIATION MEASURING INSTRUMENT1Cleared 510(K)
- K821494RIA STAT 161Cleared 510(K)
- K820376MICROMEDIC SYSTEMS ISOFLEX1Cleared 510(K)
- K820137IMMU-COUNT1Cleared 510(K)
- K813472LS 5800 SERIES LIQUID SCINTILLATION1Cleared 510(K)
- K810345LIQUID SCINTILLATION SPECTROPHOTOMETER1Cleared 510(K)
- K802578PACE-4-AUTOMATIC RIA GAMMA-COUTER1Cleared 510(K)
- K801264NUCLEAR ENTERPRISES 1600/GAMMA COUNTER1Cleared 510(K)
- K801263NUCLEAR ENTERPRISES 1612 MULTI-WELL1Cleared 510(K)
- K801245ATOMLIGHT (LIQUID SCINTILLATION SOLUTION1Cleared 510(K)
- K800601HYDRAGAMMA 161Cleared 510(K)
- K800388NML 5000 AUTO. GAMMA SCINT. COUNTER1Cleared 510(K)
- K790961LIQUID SCINTILLATION COUNTER1Cleared 510(K)
- K790905NUCLEAR SAMPLE READER1Cleared 510(K)
- K780790IDI 200 GAMMA COUNTER1Cleared 510(K)
- K780341SCINTILLATION, LIQUID, RACKBETA1Cleared 510(K)
- K780344GAMMA COUNTER1Cleared 510(K)
- K771614AUTO. WELL TYPE GAMMA COUNTERS1Cleared 510(K)
- K771612WELL TYPE GAMMA COUNTER1Cleared 510(K)
- K771613WELL TYPE GAMMA COUNTER1Cleared 510(K)
- K780383COUNTER, RADIOASSAY, AUTO., MICROMEDIC1Cleared 510(K)
- K780179LIQUID SCINTILLATION COUNTER1Cleared 510(K)
- K772099PRINTER1Cleared 510(K)
- K771369LIQ. SCINTILLATION SPECTROPHOTOMETEO1Cleared 510(K)
- K771129AUTO-LOGIC II SYSTEM1Cleared 510(K)
- K771180GAMMA GOUNTING SYS., AUTO, MODEL 14001Cleared 510(K)
- K770740RADIOASSAY TUBES & RADIOASSAY TUBE CAPS1Cleared 510(K)
- K770572DP-5000 DATA REDUCTION SYSTEM1Cleared 510(K)
- K770088GAMMA 4000 SCINTILLATION COUNTER1Cleared 510(K)
- K761214WELL COUNTERS, LOGIC II (200 SERIES)1Cleared 510(K)
- K760900GAMMA SCINTILLATION COUNTER1Cleared 510(K)
- K760424LIQUID SCINTILLATION COUNTER1Cleared 510(K)
- K760828BLASTOMYCES YEAST ANTIGEN1Cleared 510(K)
- K760470COUNTER, RACK GAMMA (#1270)1Cleared 510(K)
- 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
- 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
PRINTER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K772099
- 510(k) Type
- Traditional
- Applicant
- MILES LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/26/1978
- Days to Decision
- 80 days