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
- K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEM1Cleared 510(K)
- K980120DIGENE DML 2000 MICROPLATE LUMINOMETER1Cleared 510(K)
- K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER1Cleared 510(K)
- K974762STAT TRACKS1Cleared 510(K)
- K962113ANTHOS PHACTS VERSION MICROPLATE READER1Cleared 510(K)
- K961183CBI 7520 READER1Cleared 510(K)
- K962166ORIGEN ANALYZER1Cleared 510(K)
- K955077ANTHOS 2010 READER1Cleared 510(K)
- K953710ELX808 AUTOMATED MICROPLATE READERS1Cleared 510(K)
- K953572ELX800UV1Cleared 510(K)
- K953005BILI-METER1Cleared 510(K)
- K9500295STRATEC SL 300 LIA-MAT1Cleared 510(K)
- K940486DIGENE DCR-1 LUMINOMETER1Cleared 510(K)
- K942361WHITSOFT1Cleared 510(K)
- K942250BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER1Cleared 510(K)
- K942245BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE1Cleared 510(K)
- K950104ELX800 AND EL800 AUTOMATED MICROPLATE READERS1Cleared 510(K)
- K942923CERES 900C & CERES UV900C1Cleared 510(K)
- K943454PLATO 3300/13001Cleared 510(K)
- K935983MICROREADER 41Cleared 510(K)
- K943595SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM1Cleared 510(K)
- K941050DUPONT ACA STAR1Cleared 510(K)
- K943701MRX MICROPLATE READER1Cleared 510(K)
- K932778BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER1Cleared 510(K)
- K932467ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM1Cleared 510(K)
- K921536ACCULYTE CHEMILUMINESCENCE ANALYZER1Cleared 510(K)
- K931907ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III1Cleared 510(K)
- K925625OMNI1Cleared 510(K)
- K925935OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER1Cleared 510(K)
- K923844LYRIS 100/120 LABORATORY INFORMATION SYSTEM1Cleared 510(K)
- K925203TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.11Cleared 510(K)
- K923158LUMICO ANALYZER SA-3001Cleared 510(K)
- K922976LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT1Cleared 510(K)
- K922329BERTHOLD LB 9541Cleared 510(K)
- K923456MICROLITE MICROTITER PLATE LUMINOMETER ML30001Cleared 510(K)
- K922081LABOTECH AUTOMATED MICROTITER ANALYZER1Cleared 510(K)
- K921180COBAS CORE IMMUNOCHEMISTRY SYSTEM1Cleared 510(K)
- K915896MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI1Cleared 510(K)
- K915690SLT 340 ATTC1Cleared 510(K)
- K915689SLT SPECTRA1Cleared 510(K)
- K920914MP/S SINGLE WAVELENGTH MINI PHOTOMETER1Cleared 510(K)
- K915113ENCORE1Cleared 510(K)
- K915680AMERLITE PROCESSING CENTER1Cleared 510(K)
- K914906AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT1Cleared 510(K)
- K913590MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER1Cleared 510(K)
- K914202BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE1Cleared 510(K)
- K913840MICROTAK PLUS1Cleared 510(K)
- K913295OPUS(R) PLUS ANALYZER1Cleared 510(K)
- K912368IMX SELECT ANALYZER1Cleared 510(K)
- K910806METROLAB MODEL 15001Cleared 510(K)
- K912959MICROTRAK MANAGER1Cleared 510(K)
- K912413CHEM-LINK DATA BASE MANAGER1Cleared 510(K)
- K911045OBA(TM) READER1Cleared 510(K)
- K911438TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE1Cleared 510(K)
- K904783DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER1Cleared 510(K)
- K910740SLT MICROPLATE WASHER1Cleared 510(K)
- K910302ECLIPSE ICA ANALYZER1Cleared 510(K)
- K904567DYNATECH MR4000 MICROPLATE READER1Cleared 510(K)
- K905762GEN-PROBE LUMINOMETER-LEADER 4501Cleared 510(K)
- K905215IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER1Cleared 510(K)
- K903911GEN-PROBE PAL LUMINOMETER1Cleared 510(K)
- K903934GEN-PROBE LUMINOMETER-LEADER 501Cleared 510(K)
- K903164EURAMARK 610 PHOTOMETER1Cleared 510(K)
- K902776SPECTROPHOTOMETER (MICROASSAY PLATE READERS)1Cleared 510(K)
- K901829BEHRING CHROMOTIMER1Cleared 510(K)
- K901695QUICK CHEM II1Cleared 510(K)
- K901965MPR-4A - MICRO-PLATE READER1Cleared 510(K)
- K901542E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE1Cleared 510(K)
- K900245DU PONT VISTA(R) IMMUNOASSAY SYSTEM1Cleared 510(K)
- K901027AUTOMATED EIA MICROPLATE READER MODELS EL312/312I1Cleared 510(K)
- K901059AUTOMATED EIA MICROPLATE READER MODELS EL340/340I1Cleared 510(K)
- K900776NOVAPATH MICROPLATE READER1Cleared 510(K)
- K900224STAT FAX(TM)-21001Cleared 510(K)
- K900579AUTOREADER CALIBRATION TEST PLATE1Cleared 510(K)
- K900372BIOTRACK IMMUNOCHEMISTRY MONITOR1Cleared 510(K)
- K900028ALLERCOAT MICROPLATE SYSTEM1Cleared 510(K)
- K894423ACC.U.DIAL1Cleared 510(K)
- K896007COBAS READY1Cleared 510(K)
- K896117MODIFIED MODEL 535(TM) LUMINOMETER1Cleared 510(K)
- K894859LP 400 MICROPLATE READER1Cleared 510(K)
- K895967FASTEC 901 AGGLUTINATION PATTERN READER1Cleared 510(K)
- K895313MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER1Cleared 510(K)
- K895102BIOTRACK PDS MONITOR1Cleared 510(K)
- K894503GEMTAB SYSTEM1Cleared 510(K)
- K894687DYNATECH MR 5000, CATALOG #011-976-06001Cleared 510(K)
- K894270DENLEY ANTHOS 2001 READER1Cleared 510(K)
- K893738QUIDEL REFLECTANCE ANALYZER1Cleared 510(K)
- K891767GENETIC SYSTEMS MICROPLATE READER1Cleared 510(K)
- K891270MICROTRAK EIA AUTOREADER1Cleared 510(K)
- K892063THERMOMAX MICROPLATE READER, MODIFICATION1Cleared 510(K)
- K891869CLS 962 MICROPLATE PHOTOMETER1Cleared 510(K)
- K890854EIA READER MODEL EL3011Cleared 510(K)
- K890502MICROLITE TUBE LUMINOMETER #011-902-00001Cleared 510(K)
- K884782MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)1Cleared 510(K)
- K884864PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO1Cleared 510(K)
- K884124AUTOMATED EIA READER MODEL EL3111Cleared 510(K)
- K883646BEHRING TURBITIMER1Cleared 510(K)
- K883435NOVASPEC II SPECTROPHOTOMETER1Cleared 510(K)
- K883302EMAX PRECISION MICROPLATE READER1Cleared 510(K)
- K882938STAT FAX(TM)1Cleared 510(K)
- K882608LAD MODEL 633 LUMINOMETER1Cleared 510(K)
- K882095MODIFICATION OF BEHRING RAPIMAT II/T1Cleared 510(K)
- K881458ASTROSCAN 2100 MICROTITER PLATE READER1Cleared 510(K)
- K881797EASY WASHER II MICROPLATE WASHER1Cleared 510(K)
- K881877COBAS EIA(TM) PHOTOMETER1Cleared 510(K)
- K881803UVMAX KINETIC MICROPLATE READER1Cleared 510(K)
- K873893LUMICON1Cleared 510(K)
- K874262LAD MODEL 735 LUMINOMETER1Cleared 510(K)
- K873384CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA1Cleared 510(K)
- K873451PROJECT 300 MICROASSAY BP-12, EIA MINILAB1Cleared 510(K)
- K874244DYNATECH MR 300 MANUAL MICROELISA1Cleared 510(K)
- K873678SPECTROPHOTOMETER (MICROASSAY PLATE READERS)1Cleared 510(K)
- K873638MICRO-CHEM ANALYZER1Cleared 510(K)
- K873583AUTO-EIA1Cleared 510(K)
- K872749SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 10001Cleared 510(K)
- K873138MICRO-READER II1Cleared 510(K)
- K873408MODEL 690 SPECTROPHOTOMETER1Cleared 510(K)
- K872219GEN-PROBE (R) LUMINOMETER - LEADER (TM)1Cleared 510(K)
- K872324LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT1Cleared 510(K)
- K871874CIBA CORNING MAGIC LITE ANALYZER II1Cleared 510(K)
- K871307SYVA Q-SPEC PHOTOMETER1Cleared 510(K)
- K871415MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)1Cleared 510(K)
- K864542ARTEL DIFFERENTIAL PHOTOMETER1Cleared 510(K)
- K864451UV VISIBLE SPECTROPHOTOMETERS1Cleared 510(K)
- K864566ADX(TM) ANALYZER1Cleared 510(K)
- K864201LAD MODEL 535 LUMINOMETER1Cleared 510(K)
- K863959OHMEDA 6000 MULTI-GAS MONITOR1Cleared 510(K)
- K864285TERUMO OVATION SPECTROPHOTOMETER1Cleared 510(K)
- K864634AP1 COLORIMETER1Cleared 510(K)
- K864319TDX(R) II ANALYZER1Cleared 510(K)
- K864060MICRO-READER1Cleared 510(K)
- K863802VMAX KINETIC MICROPLATE READER1Cleared 510(K)
- K863566GSC 10001Cleared 510(K)
- K861263BEHRING RAPIMAT II1Cleared 510(K)
- K862999ULTRASCAN CLINICAL ANALYZER1Cleared 510(K)
- K862908AKERSCAN COLORIMETRIC ANALYZER1Cleared 510(K)
- K861897UNISKAN II1Cleared 510(K)
- K860720BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)1Cleared 510(K)
- K861617THE PARTNER SPECTROPHOTOMETER1Cleared 510(K)
- K861223THE JR. PARTNER SPECTROPHOTOMETER1Cleared 510(K)
- K860987MINI-CHEM ANALYZER1Cleared 510(K)
- K861194ULTROSPEC K KINETICS SPECTROPHOTOMETER1Cleared 510(K)
- K855108RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR1Cleared 510(K)
- K854679PHOTIC-100 SPECTROPHOTOMETER1Cleared 510(K)
- K855149COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER1Cleared 510(K)
- K854210TERUMO SENSIBEAD EIA COLORIMETER1Cleared 510(K)
- K854540RAICHEM/K.E1Cleared 510(K)
- K854303MR 700 MICROPLATE READER 012-700-10001Cleared 510(K)
- K853284MYREADER 71Cleared 510(K)
- K853453BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER1Cleared 510(K)
- K852411MR 650 MICROPLATE READER(CAT. NO. 011-973-0500)1Cleared 510(K)
- K852538LKB 4057 ULTROSPEC II E1Cleared 510(K)
- K852481UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM1Cleared 510(K)
- K844894PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES1Cleared 510(K)
- K852047SC-360 SPECTROPHOTOMETER1Cleared 510(K)
- K851572NOVASPEC VISIBLE SPECTROPHOTOMETER1Cleared 510(K)
- K850995SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P1Cleared 510(K)
- K850994SPECTRA 1 FILTER PHOTOMETER1Cleared 510(K)
- K850993SMART ALEX II MULTI-FILTER PHOTOMETER1Cleared 510(K)
- K851098BEHRING VECTOR PHOTOMETER1Cleared 510(K)
- K850392INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS1Cleared 510(K)
- K844567TITERTEK TWINREADER 78-630-001Cleared 510(K)
- K844418TITERTEK MULTISKAN MCC1Cleared 510(K)
- K844419TITERTEK MULTISKAN MSS/3401Cleared 510(K)
- K850767SPECTRONIC 2000 SPECTROPHOTOMETER1Cleared 510(K)
- K850709SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER1Cleared 510(K)
- K850348UROTRON RL91Cleared 510(K)
- K850708SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER1Cleared 510(K)
- K842474GLUCOCHEK III1Cleared 510(K)
- K843668PHOTOMETER 90IYS1Cleared 510(K)
- K841648DIAGEM DIGITAL BLOOD GLUCOSE MONITOR1Cleared 510(K)
- K843460ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER1Cleared 510(K)
- K842947MICROBIOLOGICAL TRAY READER-MANUAL1Cleared 510(K)
- K842770MACBETH COLOR EIAD 100/100PC1Cleared 510(K)
- K843296ELVI 675 DIGITRON1Cleared 510(K)
- K842311CHEMISTRY ANALYZER, GEN. PURPOSE1Cleared 510(K)
- K842085AUTOMATED EIA MICROPLATE READER EL3101Cleared 510(K)
- K841557ORTHO MICROWELL READER1Cleared 510(K)
- K841214LABSYSTEMS UNISKAN1Cleared 510(K)
- K840340CHEM-STAT ANALYZER1Cleared 510(K)
- K834489ULTROSPEC W/APPLE II -4050-1Cleared 510(K)
- K834099BLOOD GLUCOSE MONITOR1Cleared 510(K)
- K834150STRIP SPLITTER II -HALF WIDTH CARRIER1Cleared 510(K)
- K832531PHOTOMETER LP 3001Cleared 510(K)
- K832397HYBRITECH 405-500 NM FILTER MODULE1Cleared 510(K)
- K832364PHOTON IMMUNOASSAY ANALYZER1Cleared 510(K)
- K832206SPECTROPHOTOMETER #3901Cleared 510(K)
- K831866MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC1Cleared 510(K)
- K830569CYNOX I HEMOGLOBINOMETER1Cleared 510(K)
- K823512MR 600 MICROPLATE READER1Cleared 510(K)
- K823590MANUALISA MICROTITRATION PLATE READER1Cleared 510(K)
- K830101COLORIMETERS SERIES ONE 121Cleared 510(K)
- K823720SPECTROPHOTOMETER1Cleared 510(K)
- K823266POSITIVE I.D. SYSTEM1Cleared 510(K)
- K822800PICOLITE1Cleared 510(K)
- K822720MODEL 340 SPECTROPHOTOMETER1Cleared 510(K)
- K822050STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO1Cleared 510(K)
- K821561VERSACHEM ANALYZER1Cleared 510(K)
- K821439MR 600 MICROPLATE READER1Cleared 510(K)
- K813563PHADEZYM ANALYZER1Cleared 510(K)
- K8202734050/4051 ULTRASPEC1Cleared 510(K)
- K820217LKB-WALLACE 1251 LUMINOMETER1Cleared 510(K)
- K812865QUANTUMATIC DUAL-WAVELENGTH SPECTRO1Cleared 510(K)
- K811975MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL1Cleared 510(K)
- K811680ACCUDEX1Cleared 510(K)
- K811840BILIRUBINOMETER1Cleared 510(K)
- K811806QUICK-CHEM COLORIMETER1Cleared 510(K)
- K811111AUTOMATIC ELISA READER1Cleared 510(K)
- K810665GILUCOCHEK REFLECTANCE METER1Cleared 510(K)
- K810736LUMINESCENCE PHOTOMETER 100 SERIES1Cleared 510(K)
- K810511BECKMAN DU-8 SPECTROPHOTOMETER1Cleared 510(K)
- K810105BCA 10001Cleared 510(K)
- K803285PHOTOMETER1Cleared 510(K)
- K803131LKB-WALLACE 1250 LUMINOMETER1Cleared 510(K)
- K803030THE BIO-TEK CHROMOSCAN1Cleared 510(K)
- K802619DRUG DETECTION SYSTEM1Cleared 510(K)
- K801957MICRO-FLOW SPECTROPHOTOMETER CL-7201Cleared 510(K)
- K801536BLOOD GLUCOSE TESTER1Cleared 510(K)
- K801564PHOTOMETER LP 11Cleared 510(K)
- K801563PHOTOMETER LP 31Cleared 510(K)
- K801562PHOTOMETER LP 61Cleared 510(K)
- K801499AGA UV PHOTOMETER1Cleared 510(K)
- K801373BECKMAN MODEL 42 SPECTROPHOTOMETER1Cleared 510(K)
- K801044AMES GLUCOMETER REFLECT. PHOTOMETER1Cleared 510(K)
- K800522MICRO ELISA AUTO READER1Cleared 510(K)
- K800523MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC.1Cleared 510(K)
- K792647AUTOSCAN 31Cleared 510(K)
- K800057MICRO ELISA MINI READER1Cleared 510(K)
- K792292AMES DEXTROMETER REFLECTANCE COLORIMETER1Cleared 510(K)
- K791968EIA (ELISA) READER1Cleared 510(K)
- K791302MANUAL MICRO ELISA READER #2-5301Cleared 510(K)
- K791102CARY 210 SERIES, SPECTROPHOTOMETER1Cleared 510(K)
- K790422MULTISKAN (78-503-00)1Cleared 510(K)
- K782035HEMESPEC1Cleared 510(K)
- K781632UROTRON1Cleared 510(K)
- K781269ELISA SYSTME1Cleared 510(K)
- K781576MINI-KEM1Cleared 510(K)
- K781544EPPENDORF PCP 61211Cleared 510(K)
- K781241UNISTAT BILIRUBINOMETER1Cleared 510(K)
- K781138SPECTROPHOTOMETER1Cleared 510(K)
- K780903CLINICAL ANALYZER SYSTEM1Cleared 510(K)
- K780902FISHER SPECTROPHOTOMETER1Cleared 510(K)
- K780156SPECTROPHOTOMETER, MODEL 3801Cleared 510(K)
- K771909DUAL WAVELENGTH PHOTOMETER, 11771Cleared 510(K)
- K771807SPECTROPHOTOMETER ANALYSIS SYS.1Cleared 510(K)
- K772022SPECTROPHOTOMETER CARY 2191Cleared 510(K)
- K771637SPECTROPHOTOMETER ANALYSIS SYSTEM1Cleared 510(K)
- K771496CHEMCODE/CHEMTEK SYSTEM1Cleared 510(K)
- K770306ANALYZER, 751 KINETIC/ENDPOINT1Cleared 510(K)
- K770288SPECTROPHOTOMETER, MODEL 597 IR1Cleared 510(K)
- K770278SPECTROPHOTOMETERS, INFRARED MODELS X991Cleared 510(K)
- K760737SCATTERED TRANSMISSION ACCESSORY1Cleared 510(K)
- K760553PRINTER1Cleared 510(K)
- K760395PHOTOMETER, SEROMETER (MODEL 380)1Cleared 510(K)
- K760672CLINICAL SPECTROPHOTOMETER1Cleared 510(K)
- K760232PRINTER, IL 4601Cleared 510(K)
- K760233TABLE, SAMPLE IL 4611Cleared 510(K)
- K760112SPECTROPHOTOMETER (JUNIOR III)1Cleared 510(K)
- 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
ENCORE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K915113
- 510(k) Type
- Traditional
- Applicant
- HERAEUS KULZER, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/18/1992
- Days to Decision
- 126 days
- Submission Type
- Summary