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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
- K183205PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System1Cleared 510(K)
- K103340SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM1Cleared 510(K)
- K081345AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)1Cleared 510(K)
- K071934MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT1Cleared 510(K)
- K070666GENESISCS COMPONENT CONCENTRATING SYSTEM1Cleared 510(K)
- K052925SMARTPREP2 CENTRIFUGE SYSTEM1Cleared 510(K)
- K042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM1Cleared 510(K)
- K024080SECQUIRE CELL SEPARATOR1Cleared 510(K)
- K030555GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A1Cleared 510(K)
- K030340AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)1Cleared 510(K)
- K021902MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT3001Cleared 510(K)
- K9941483I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM1Cleared 510(K)
- K991430SMARTPREP CENTRIFUGE SYSTEM1Cleared 510(K)
- K944738SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE1Cleared 510(K)
- K881254STATSPIN DISPOSABLE ROTOR, PRODUCT #RD011Cleared 510(K)
- K864974GENERAL PURPOSE CENTRIFUGE1Cleared 510(K)
- K861146MODEL K110SX CENTRIFUGE1Cleared 510(K)
- K860747DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)1Cleared 510(K)
- K860172QWIKSPIN (TM)1Cleared 510(K)
- K850485ROTOR SYSTEMS A/S-400 & LA/S-4001Cleared 510(K)
- K843434ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.1Cleared 510(K)
- K843088EBA 3 S CENTRIFUGE1Cleared 510(K)
- K843087UNIVERSAL 2 S CENTRIFUGE1Cleared 510(K)
- K840768CENTRIFUGES1Cleared 510(K)
- K831942LKB 2164 MACRO-SPIN R CENTRIFUGE1Cleared 510(K)
- K831947LKB 2160 MIDISPIN CENTRIFUGE1Cleared 510(K)
- K831948LKB 2161 MIDISPIN R CENTRIFUGE1Cleared 510(K)
- K822715PLATELET CENTRIFUGE1Cleared 510(K)
- K822422BASIC CENTRIFUGE1Cleared 510(K)
- K821756IEC CENTRA 4 CENTRIFUGE1Cleared 510(K)
- K813524CENTIDISC1Cleared 510(K)
- K812505PALL ULTIPOR VACUUM LINE BACTERIA FITLER1Cleared 510(K)
- K810833SORVALL RT6000 REFRIGERATED TABLETOP1Cleared 510(K)
- K802210CONICAL TIPPED CENTRIFUGE TUBE 15M1Cleared 510(K)
- K800381REFRIG. CENTRIFUGE (DRUCKER MODEL)1Cleared 510(K)
- K782124IEC CENTRA-7 CENTRIFUGE MODEL 23621Cleared 510(K)
- K761013SPINETTE CENTRIFUGE1Cleared 510(K)
- K760467ROTATOR, FIXED SPEED1Cleared 510(K)
- 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
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K994148
- 510(k) Type
- Traditional
- Applicant
- IMPLANT INNOVATIONS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/1/2000
- Days to Decision
- 55 days
- Submission Type
- Summary