Anesthesiology
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- 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
- K052794ETI-MAX 30001Cleared 510(K)
- K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER1Cleared 510(K)
- K033734LIGHTCYCLER INSTRUMENT VERSION 1.21Cleared 510(K)
- K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER1Cleared 510(K)
- K012966ROCHE COBAS TAQMAN ANALYZER1Cleared 510(K)
- K993634CARESIDE ANALYZER1Cleared 510(K)
- K973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA1Cleared 510(K)
- K980056CARESIDE ANALYZER1Cleared 510(K)
- K973177MAGO AUTOMATED EIA PROCESSOR1Cleared 510(K)
- K971491SYNERMED IR 200 CHEMISTRY ANALYZER1Cleared 510(K)
- K964506ROCHE COBAS AMPLICOR ANALYZER1Cleared 510(K)
- K965103WINMAX SOFTWARE SYSTEMS1Cleared 510(K)
- K964409HCL - 200 BIOCHEMISTRY ANALYZER1Cleared 510(K)
- K961209BRIO AUTOMATIC SAMPLINC UNIT1Cleared 510(K)
- K943978WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS1Cleared 510(K)
- K942676SYNCHRON CX3 DELTA1Cleared 510(K)
- K925093SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA1Cleared 510(K)
- K912055SYVA EDMS1Cleared 510(K)
- K903357SYVA(R) ETS(R) PLUS SYSTEM1Cleared 510(K)
- K893768MODIFIED PK300 AUTOMATIC EIA ANALYZER1Cleared 510(K)
- K883350RECONDITIONED ASTRA(TM) 41Cleared 510(K)
- K883298RECONDITIONED ASTRA (TM) 81Cleared 510(K)
- K883020RFA-300 RAPID FLOW ANALYZER W/COMPUTER1Cleared 510(K)
- K872120SERALYZER III BLOOD CHEMISTRY ANALYZER1Cleared 510(K)
- K871486(FPIA) ASSAY BUFFER1Cleared 510(K)
- K870777PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER1Cleared 510(K)
- K863245SYVA ETS SYSTEM1Cleared 510(K)
- K864834OLYMPUS PK3001Cleared 510(K)
- K864236SYNCHRON CX31Cleared 510(K)
- K852385HYBRITECH IMMUNOCHEMISTRY ANALYZER1Cleared 510(K)
- K851933CLINICAL CHEMISTRY ANALYTICAL SYSTEM1Cleared 510(K)
- K851542RFA-300 RAPID FLOW ANALYZER W/COMPUTER1Cleared 510(K)
- K851172COBAS MIRA1Cleared 510(K)
- K850999TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN1Cleared 510(K)
- K844586IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS1Cleared 510(K)
- K840200PROGRESS SELECTIVE DHEMISTRY ANALYZ1Cleared 510(K)
- K833998QCA CHEMISTRY ANALYZER1Cleared 510(K)
- K833804SHABAN 9865 IL#78637 JUNCTION BLOC1Cleared 510(K)
- K833154NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM1Cleared 510(K)
- K833153NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU1Cleared 510(K)
- K831227COMPUR EASY TOUCH CHEMISTRY ANALYZER-1Cleared 510(K)
- K830095RAPID CHEM ANALYZER II1Cleared 510(K)
- K821583AMES/GILFORD OPTIMATE CLIN. CHEM & THER1Cleared 510(K)
- K820541MICROLYTE1Cleared 510(K)
- K820748POLI-MAK MODEL F-4 (FINAL1Cleared 510(K)
- K8204154150 ALPHA AMINO ACID ANALYZER1Cleared 510(K)
- K803004AMINO ACID ANALYSER SYSTEM1Cleared 510(K)
- K802398ELECTROLY TE CHEMISTRY ANALYZER1Cleared 510(K)
- K802264WASH SOLUTION KIT, #881021Cleared 510(K)
- K802392ASTRA PRINTER PAPER #88112-CHLORIDE SILV1Cleared 510(K)
- K790197REAGENT KIT, LANCER GLUCOSE1Cleared 510(K)
- K790335HYCEL M1Cleared 510(K)
- K781606MEPA-1 BLOOD ANALYZER1Cleared 510(K)
- K781442BECKMAN ASTRA SYSTEM1Cleared 510(K)
- K771821STAC SYSTEM1Cleared 510(K)
- K771939STAC SYSTEM-ADDI. ANALYTES1Cleared 510(K)
- K771513KEM-O-MAT1Cleared 510(K)
- 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
- 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
AMES/GILFORD OPTIMATE CLIN. CHEM & THER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K821583
- 510(k) Type
- Traditional
- Applicant
- GILFORD INSTRUMENT LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/24/1982
- Days to Decision
- 27 days