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
- K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode1Cleared 510(K)
- K133519CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR1Cleared 510(K)
- K130915XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK1Cleared 510(K)
- K131554RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT1Cleared 510(K)
- K130276DIMENSION EXL WITH LM SYSTEM1Cleared 510(K)
- K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT1Cleared 510(K)
- K112999DIMENSION CLINICAL CHEMISTRY SYSTEM1Cleared 510(K)
- K110035INDIKO1Cleared 510(K)
- K073370TC MATRIX CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K063144VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM1Cleared 510(K)
- K051087DIMENSION VISTA INTEGRATED SYSTEM1Cleared 510(K)
- P910007ABBOTT IMX TOTAL PSA1PMA Approval
- K042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K040958PRESTIGE MODELS 24I AND 400 AND MGC MODEL 2401Cleared 510(K)
- P910007ABBOTT AXSYM TOTAL PSA ASSAY1PMA Approval
- P910007ABBOTT ARCHITECT TOTAL PSA1PMA Approval
- K023764UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 9731001Cleared 510(K)
- K010500AUTOMATED WORKCELL CONTROL SOFTWARE1Cleared 510(K)
- K003721MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K002982OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K983345BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY1Cleared 510(K)
- K974779ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER1Cleared 510(K)
- K974651ABBOTT AXSYM SYSTEM1Cleared 510(K)
- K971761PERSONALLAB AUTOMATED MICROPLATE ANALYZER1Cleared 510(K)
- K970227IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER1Cleared 510(K)
- K965240SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L1Cleared 510(K)
- K961142STRATEC LIA II ANALYZER1Cleared 510(K)
- K963539SIGMA DIAGNOSTICS WASH CONCENTRATE1Cleared 510(K)
- K962231COBAS CORE IMMUNOCHEMISTRY SYSTEM1Cleared 510(K)
- K962125TECHNICON IMMUNO 1 SYSTEM1Cleared 510(K)
- K961274OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K962235VITROS SPECIALTY DILUENT1Cleared 510(K)
- K961481ELECSYS 2010 ANALYZER1Cleared 510(K)
- K953239BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER1Cleared 510(K)
- K942922SELECTA 20/60 CHEMISTRY ANALYZER1Cleared 510(K)
- K951189SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.01Cleared 510(K)
- K945566ABBOTT PROJECT I, SPECTRUM1Cleared 510(K)
- K950915ABBOTT AXSYM II SYSTEM1Cleared 510(K)
- K950958SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)1Cleared 510(K)
- K950353TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM1Cleared 510(K)
- K945271ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM1Cleared 510(K)
- K945135MICROPLATE PROCESSOR 30001Cleared 510(K)
- K943493DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER1Cleared 510(K)
- K946090KODAK EKTACCHEM 950IRC ANALYZER1Cleared 510(K)
- K944028PROCHEM CHEMISTRY ANALYZER1Cleared 510(K)
- K944093DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM1Cleared 510(K)
- K942364HITACHI 914 ANALYZER1Cleared 510(K)
- K942443AURAFLEX SYSTEMS1Cleared 510(K)
- K940289ABBOTT PRISM ANALYZER1Cleared 510(K)
- K940810CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF1Cleared 510(K)
- K933703SIGMA WASH CONCENTRATE SOLUTION1Cleared 510(K)
- K933548ELS 10001Cleared 510(K)
- K931786ACE CLINICAL CHEMISTRY SYSTEM1Cleared 510(K)
- K931744OLYMPUS REPLY GLUCOSE REAGENT1Cleared 510(K)
- K930489AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS1Cleared 510(K)
- K926060SYNCHRON CX5CE CLINICAL ANALYZER1Cleared 510(K)
- K923579MINIVIDAS INSTRUMENT1Cleared 510(K)
- K924084ATAC 6000 CHEMISTRY ANALYZER1Cleared 510(K)
- K923060IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY1Cleared 510(K)
- K922680DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT1Cleared 510(K)
- K922139VISTA IMMUNOASSAY SYSTEM -- MODIFICATION1Cleared 510(K)
- K922072KODAK EKTACHEM 250 ANALYER1Cleared 510(K)
- K921661BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER1Cleared 510(K)
- K922220OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K920402ROCHE COBAS MIRA PLUS1Cleared 510(K)
- K915366MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K915106DIMENSION AR CLINICAL CHEMISTRY SYSTEM1Cleared 510(K)
- K912844KODAK EKTACHEM DTII SYSTEM1Cleared 510(K)
- K912024AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)1Cleared 510(K)
- K910185SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER1Cleared 510(K)
- K904219SYNCHRON CX 7 CLINICAL ANALYZER1Cleared 510(K)
- K904220SYNCHRON CX4-CE1Cleared 510(K)
- K903071KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN1Cleared 510(K)
- K902689ATAC 6000 CHEMISTRY ANALYZER1Cleared 510(K)
- K902336CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE1Cleared 510(K)
- K901346ES 300 IMMUNOASSAY SYSTEM1Cleared 510(K)
- K901003BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER1Cleared 510(K)
- K895423ACCESS CHEMISTRY ANALYZER1Cleared 510(K)
- K894222TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL1Cleared 510(K)
- K893137EXCEL (TM) CHEMISTRY ANALYZER1Cleared 510(K)
- K893776ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K893547CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER1Cleared 510(K)
- K890929KODAK EKTACHEM 750 SERIES ANALYZER1Cleared 510(K)
- K890927KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.01Cleared 510(K)
- K890928KODAK EKTACHEM 500 ANALYZER1Cleared 510(K)
- K884378DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K885226TECHNICON AXON(TM) SYSTEM1Cleared 510(K)
- K890184MODIFIED INTENDED USE OF CLEANING REAGENT KIT1Cleared 510(K)
- K890183MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.1Cleared 510(K)
- K885288HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE1Cleared 510(K)
- K885289KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.01Cleared 510(K)
- K884035SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER1Cleared 510(K)
- K883533ABC FP ANALYZER1Cleared 510(K)
- K883539SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER1Cleared 510(K)
- K883321CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST1Cleared 510(K)
- K883209TECHNICON RA-100(TM) SYSTEM1Cleared 510(K)
- K882451OLYMPUS REPLY CHEMISTRY ANALYZER1Cleared 510(K)
- K882913DTR ANALYZER1Cleared 510(K)
- K882914VISTA INSTRUMENT1Cleared 510(K)
- K882559PROFILE ONE OMNI1Cleared 510(K)
- K882194GEMINII GAMMA COUNTER1Cleared 510(K)
- K882307D-CHEM1Cleared 510(K)
- K882450GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.1Cleared 510(K)
- K882081SPECIFIC CHEMISTRY ANALYZER1Cleared 510(K)
- K881498SYNCHRON CX(TM)4 CLINICAL ANALYZER1Cleared 510(K)
- K881495SYNCHRON CX(TM)5 CLINICAL ANALYZER1Cleared 510(K)
- K874857KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.01Cleared 510(K)
- K873130WASH SOLUTION KIT1Cleared 510(K)
- K873749CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER1Cleared 510(K)
- K873617GEMSTAR II SYSTEM1Cleared 510(K)
- K872302MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K864849ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER1Cleared 510(K)
- K872813EASY ST ANALYZER SYSTEM1Cleared 510(K)
- K872494HITACHI 717 CHEMISTRY ANALYZER1Cleared 510(K)
- K872105KODAK EKTACHEM 700XR ANALYZER1Cleared 510(K)
- K872104KODAK EKTACHEM 700P ANALYZER1Cleared 510(K)
- K872103KODAK EKTACHEM 700S ANALYZER1Cleared 510(K)
- K870833CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY1Cleared 510(K)
- K870836ATAC 1500 CHEMISTRY ANALYZER1Cleared 510(K)
- K865105AFFINITY(TM) SYSTEM1Cleared 510(K)
- K863840METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM1Cleared 510(K)
- K863531IQ IMMUNOCHEMISTRY SYSTEM1Cleared 510(K)
- K862235CIBA CORNING MAGIC LITE ANALYZER1Cleared 510(K)
- K862818STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY1Cleared 510(K)
- K861055EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/951Cleared 510(K)
- K860748HITACHI 7361Cleared 510(K)
- K860647ES600 IMMUNOASSAY SYSTEM1Cleared 510(K)
- K860021DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM1Cleared 510(K)
- K854936EIA PROCESSOR1Cleared 510(K)
- K860080OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM1Cleared 510(K)
- K855196CLEANING REAGENT KIT PRODUCT NO 881941Cleared 510(K)
- K853621REPLACEMENT PUMP TUBING1Cleared 510(K)
- K854243ES 221Cleared 510(K)
- K854138KODAKEKTACHEM DTR MODULE1Cleared 510(K)
- K854025HITACHI 7041Cleared 510(K)
- K853391MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-20001Cleared 510(K)
- K853699EASY ANALYZER & EASY-TEST REAGENT1Cleared 510(K)
- K852133REFLOTRON SYSTEM1Cleared 510(K)
- K853003HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#881931Cleared 510(K)
- K852262ASSIST CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K851638CLINALYZER MODEL VX-10001Cleared 510(K)
- K844114ADD-11Cleared 510(K)
- K843082ANALOX LM3 MICRO-STAT ANALYSER1Cleared 510(K)
- K843059ATAC 20001Cleared 510(K)
- K843610PERSPECTIVE CHEMICAL ANALYZER1Cleared 510(K)
- K843283BOEHRINGER MANNHEIM DIAGNOSTICS ADAM1Cleared 510(K)
- K842773LABSYSTEMS FP-901 CHEMISTRY ANALYZER1Cleared 510(K)
- K842500DATA MGMT. SYSTEM1Cleared 510(K)
- K841916ABBOTT PROJECT I1Cleared 510(K)
- K841503KODAK EKTACHEM DT 60 ANALYZER1Cleared 510(K)
- K840868AMRESCO E4A REAGENT SET1Cleared 510(K)
- K840883UNIPAK 100 ANALYZER, 65156 & CHEMISTR1Cleared 510(K)
- K841076ION SELECTIVE ELECTRODE1Cleared 510(K)
- K840501ACCULAB SUPPLIES CHEMICAL ANALYZERS1Cleared 510(K)
- K840120ADVANTAGE1Cleared 510(K)
- K840129UNI-FAST ANALYZER SYSTEM1Cleared 510(K)
- K834534APSARA ANALYZER1Cleared 510(K)
- K834521DISCRETE CLINICAL ANALYZER1Cleared 510(K)
- K833833KODAK EKTACHEM 700 ANALYZER1Cleared 510(K)
- K832115ATAC 30001Cleared 510(K)
- K833448EPOS CHEMISTRY ANALYZER 5060 & 64101Cleared 510(K)
- K833067IMPACT 400 #1447X21Cleared 510(K)
- K833116SPIRIT CHEMISTRY SYSTEM1Cleared 510(K)
- K832648ACCLAIM1Cleared 510(K)
- K832584TUBING KIT 4461Cleared 510(K)
- K831649THERMOMIXER S213-PHOTOANALYZER S2631Cleared 510(K)
- K831518AUTO CAROUSE/WASH SOLUTION CONCENTRATE1Cleared 510(K)
- K831477DEMAND ANALYZER SYSTEM1Cleared 510(K)
- K830762OLYMPUS HIGH SPEED ANALYZER1Cleared 510(K)
- K830212ELISA PLUS SYSTEM1Cleared 510(K)
- K830318PARAMAX ANALYTICAL SYS1Cleared 510(K)
- K830301STRATUS FLUOROMETRIC ENZYME IMMUN0-1Cleared 510(K)
- K823386APSARA CLINICAL DIAG. & INFO. SYS1Cleared 510(K)
- K823762VARIOUS-ANALYZER CUPS1Cleared 510(K)
- K822465ENZYMUNE SYSTEM I1Cleared 510(K)
- K821335GEMSTAR SYSTEM1Cleared 510(K)
- K8208888700 CLINICAL CHEM. ANALYZER1Cleared 510(K)
- K820687DUPONT AUTOMATIC CLINICAL ANALYZER1Cleared 510(K)
- K820118ELECTROLYTE ANALYZER ACCESSORY1Cleared 510(K)
- K813160BECKMAN SYSTEM E4A1Cleared 510(K)
- K813102POLI-MAK II1Cleared 510(K)
- K811919KODAK EKTACHEM 400 ANALYZER1Cleared 510(K)
- K811194HITACHI 705 AUTOMATIC BLOOD CHEMISTRY1Cleared 510(K)
- K810549THERMAL PRINTER PAPER1Cleared 510(K)
- K810596CENTRIFI CHEM SYSTEM 400 ANALYZER1Cleared 510(K)
- K810129CENTRIFICHEM SYSTEM 5001Cleared 510(K)
- K803267AUTOMATED IMMUOCHEMISTRY SYSTEM1Cleared 510(K)
- K803135PARALLEL CHEMICAL ANALYZER1Cleared 510(K)
- K802835COMPU-CHEM II CHEMISTRY ANALYZER1Cleared 510(K)
- K802609CHEMISTRY ANALYZER IMPACT 4001Cleared 510(K)
- K802320COULTER DACOS SERUM CHEM. ANALYZER1Cleared 510(K)
- K801889MODEL 203S CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K800572KDA MICRO CHEMICAL ANALYZER1Cleared 510(K)
- K800085SYSTEM 203 CHEMISTRY ANALYZER1Cleared 510(K)
- K800053KODAK EKTACHEM FOUR CHEMISTRY ANALYZER1Cleared 510(K)
- K792361SYSTEM 103 CHEMISTRY ANALYZER1Cleared 510(K)
- K791297PRISMA1Cleared 510(K)
- K791296CHEMETRICS ANALYZER II1Cleared 510(K)
- K790072ANALYZER, IMPACT 2001Cleared 510(K)
- K782014ANALYZER ABA-2001Cleared 510(K)
- K781528COULTER ELECTROLYTE ANALYZER SYSTEM1Cleared 510(K)
- K781076CHEMISTRY ANALYZER1Cleared 510(K)
- K780464LELECTIVE KINETIC SYSTEM-601Cleared 510(K)
- K780388ANALYZER, 100, BICHROMATIC, ABBOTT1Cleared 510(K)
- K780083ANALYZER, SELECTIVE, ELECTRONIC1Cleared 510(K)
- K772344DATA ACQUISITION & COLLATING SYS.1Cleared 510(K)
- K772319ANALYZER, CLINICAL, SYSTEM 31Cleared 510(K)
- K771245MODEL 2/2 ANALYZER1Cleared 510(K)
- K771345BICHROMATIC ANALYZER ABA-2001Cleared 510(K)
- K770679CHEMISTRY, COULTER1Cleared 510(K)
- K760642ANALYZER, PROGRAMMABLE DISCRETE (PDA)1Cleared 510(K)
- 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
- 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
ABBOTT IMX TOTAL PSA
- Page Type
- PMA Approval
- Full PDF / Letter* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Abbott Laboratories
- Trade Name
- AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
- Generic Name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision Date
- 9/25/1991
- Days to Decision
- 208 days
- Decision Code
- APPR
- FDA Decision
- Approval