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
- KQOAutomated Urinalysis System1Product Code
- K141874URISCAN OPTIMA1Cleared 510(K)
- K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control1Cleared 510(K)
- K140717CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT1Cleared 510(K)
- K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL1Cleared 510(K)
- K102188CYBOW READER, MODELS 300 & 7201Cleared 510(K)
- K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT1Cleared 510(K)
- K091472URITEST 50 AND URITEST 500 URINE ANALYZER1Cleared 510(K)
- K093555COBAS U411 TEST SYSTEM1Cleared 510(K)
- K093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM1Cleared 510(K)
- K070929ACON U120 URINE ANALYZER, MODEL U111-1011Cleared 510(K)
- K053253HEMOCUE ALBUMIN 201 ANALYZING SYSTEM1Cleared 510(K)
- K051526URITEK-720+ URINE ANALYZER1Cleared 510(K)
- K042421URITEK 151 URINE ANALYZER, MODEL TC-1511Cleared 510(K)
- K031947BAYER CLINITEK STATUS ANALYZER1Cleared 510(K)
- K030600AUTION JET AJ-4270 URINE ANALYZER1Cleared 510(K)
- K013783AUTION MAX AX-4280 URINALYSIS SYSTEM1Cleared 510(K)
- K012829STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS1Cleared 510(K)
- K983510CHEMSTRIP 101 URINE ANALYZER1Cleared 510(K)
- K980047URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER1Cleared 510(K)
- K972141THE YELLOW IRIS URINALYSIS WORKSTATION1Cleared 510(K)
- K954156STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY1Cleared 510(K)
- K954514UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE1Cleared 510(K)
- K960546CLINITEK 50 URINE CHEMISTRY ANALYZER1Cleared 510(K)
- K951877AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE1Cleared 510(K)
- K954158STC DIAGNOSTICS AUTO-LYTE PH ASSAY1Cleared 510(K)
- K960054900UDX URINE PATHOLOGY SYSTEM1Cleared 510(K)
- K954024CHEMSTRIP CRITERION URINE ANALYZER1Cleared 510(K)
- K946183CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER1Cleared 510(K)
- K943592CHEMSTRIP MINI UA URINE ANALYZER1Cleared 510(K)
- K943463THE YELLOW IRIS1Cleared 510(K)
- K935408UA PERFECT1Cleared 510(K)
- K934042CHEMSTRIP SUPER UA URINE ANALYZER1Cleared 510(K)
- K932674CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM1Cleared 510(K)
- K931602CHEMSTRIP URINE ANALYZER1Cleared 510(K)
- K926359CLINITEK 200+ URINE CHEMISTRY ANALYZER1Cleared 510(K)
- K921087CHEMSTRIP URINE ANALYZER1Cleared 510(K)
- K870526SUPER URINE ANALYZER SYSTEM1Cleared 510(K)
- K841041CLINI-TEK AUTO 2000 REFLECTANCE SPECTR1Cleared 510(K)
- K842237CLINITEK 200 SEMI-AUTOMATED URINALYSIS1Cleared 510(K)
- K842238CLINITEK 10 SEMI-AUTO URINALYSIS SYS1Cleared 510(K)
- K840996URINE ANALYZER SYSTEM1Cleared 510(K)
- K830220YELLOW IRIS TM1Cleared 510(K)
- K821738CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST1Cleared 510(K)
- K813056AUTOMATED URINALYSIS SYSTEM1Cleared 510(K)
- K761306CLINILAB AUTOMATED URINALYSIS SYSTEM1Cleared 510(K)
- K760472INSTRUMENTED SYSTEM FOR URINALYSIS1Cleared 510(K)
- 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
BAYER CLINITEK STATUS ANALYZER
- Page Type
- Cleared 510(K)
- 510(k) Number
- K031947
- 510(k) Type
- Traditional
- Applicant
- BAYER HEALTHCARE, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/19/2003
- Days to Decision
- 178 days
- Submission Type
- Summary