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
- K023955BD VIPER INSTRUMENT1Cleared 510(K)
- K973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)1Cleared 510(K)
- K9801802700 SAMPLE MANAGER1Cleared 510(K)
- K970420MASTERCAP AM 5.0/MASTERCAP RM 5.01Cleared 510(K)
- K970616MINI SAMPLER PROCESSOR1Cleared 510(K)
- K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM1Cleared 510(K)
- K962859MINI SAMPLE PROCESSOR1Cleared 510(K)
- K961896MICROLAB 4000, MICROLAB 42001Cleared 510(K)
- K961694IMPACT1Cleared 510(K)
- K953345GENESIS1Cleared 510(K)
- K951753MEDTEC AUTOBLOT 20001Cleared 510(K)
- K952025ROBOCAP1Cleared 510(K)
- K9445564 CHANNEL DISPENSER1Cleared 510(K)
- K9426554 CHANNEL DISPENSER1Cleared 510(K)
- K942290STAR I WORKSTATION1Cleared 510(K)
- K941498BIOMEK SL WITH BIOMEK SL INCUBATOR1Cleared 510(K)
- K941394STAT FAX 26001Cleared 510(K)
- K940390IMPACT1Cleared 510(K)
- K936258SYSTEM WASHER 1001Cleared 510(K)
- K934124AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM1Cleared 510(K)
- K933088PLATO 30001Cleared 510(K)
- K925547MAXSOFTWARE1Cleared 510(K)
- K923879ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE1Cleared 510(K)
- K922803WELLWASH 4 MARK II1Cleared 510(K)
- K922327DENLEY WELLPREP 2 SAMPLE PROCESSOR1Cleared 510(K)
- K922183WELLPREP 2000 SAMPLE PROCESSOR1Cleared 510(K)
- K923268AFFIRM PROCESSOR1Cleared 510(K)
- K921005AUTOLOADER1Cleared 510(K)
- K915492RSP MEGA SAMPLE PROCESSOR1Cleared 510(K)
- K915284STACKING MICROPLATE WASHER1Cleared 510(K)
- K913809HY-PREP SYSTEM1Cleared 510(K)
- K913567WELLPREP 11Cleared 510(K)
- K913664ROSYS MODELS 100 AND 2001Cleared 510(K)
- K912036ROBOTIC SAMPLE PROCESSOR1Cleared 510(K)
- K912228MARK 5 ROBOTIC PIPETTOR1Cleared 510(K)
- K911712STRATUS(R) AUTOMATED SAMPLE HANDLER1Cleared 510(K)
- K910140ELECTRAPETTE (R)1Cleared 510(K)
- K902592EPC ELECTRONIC PIPETTING SYSTEM1Cleared 510(K)
- K900599MICROPLATE REAGENT DISPENSER1Cleared 510(K)
- K896684KEMBLE LIQUID HANDLING SYSTEM DISPENSER1Cleared 510(K)
- K896631EXEC-WASH SOLID PHASE WASHING SYSTEM1Cleared 510(K)
- K900775NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM1Cleared 510(K)
- K897158ABBOTT COMMANDER PARALLEL PROCESSING CENTER1Cleared 510(K)
- K893811SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM1Cleared 510(K)
- K894710DPC-ROBOSTAT(TM)1Cleared 510(K)
- K894272DENLEY WELLDILL 31Cleared 510(K)
- K894069ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER1Cleared 510(K)
- K894271DENLEY WELLWASH 2 AND 41Cleared 510(K)
- K894126ROBOTIC SAMPLE PROCESSOR1Cleared 510(K)
- K893810IMMUNO-WASH AUTOMATED TUBE WASHER1Cleared 510(K)
- K893775DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM1Cleared 510(K)
- K893400SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION)1Cleared 510(K)
- K893031DELTA (TM) ROBOTIC PIPETTOR1Cleared 510(K)
- K890578HI CHEM WASH CONCENTRATE REAGENT #888051Cleared 510(K)
- K885340AIR DISPLACEMENT PIPETTE1Cleared 510(K)
- K883470IDS-1600 SAMPLE HANDLING SYSTEM1Cleared 510(K)
- K883749PROBE(TM) MODELS 700 AND 10001Cleared 510(K)
- K881195DYNATECH SPD 2000, NUMBER 002-910-00001Cleared 510(K)
- K873416MULTI-ACCESS REAGENT DISPENSER1Cleared 510(K)
- K872363DYNATECH SPD 3000, #002-900-00001Cleared 510(K)
- K871687TYTEM(R) REAGENT DISPENSER1Cleared 510(K)
- K870544BIOMEK 1000 AUTOMATED LABORATORY WORK STATION1Cleared 510(K)
- K870406SMI DIGITRON1Cleared 510(K)
- K864875ELECTRA AUTOMATIC SAMPLER1Cleared 510(K)
- K863887SMI MULTIPETTOR(TM)1Cleared 510(K)
- K863623ULTRAWASH I1Cleared 510(K)
- K863624ULTRAWASH II1Cleared 510(K)
- K862701SURESPOT1Cleared 510(K)
- K861580PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM1Cleared 510(K)
- K861640MODUMATIC (R) DILUTER1Cleared 510(K)
- K860508POSID SAMPLER1Cleared 510(K)
- K854406TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #5001Cleared 510(K)
- K852285DADE BLOOD GAS AMPUL INJECTOR1Cleared 510(K)
- K851403VENTREZYME ALLERGEN DATA REDUCTION SYSTEM1Cleared 510(K)
- K850800DROPSTIRS - PLASTIC DISPOSABLE PIPET1Cleared 510(K)
- K844798EPPENDORF DILUTER1Cleared 510(K)
- K843779AUTOLOADER II1Cleared 510(K)
- K843621FIAX 420 DILUTOR1Cleared 510(K)
- K843607LABOPETTOR1Cleared 510(K)
- K843606PRECISION DISPENSER1Cleared 510(K)
- K842894KEMBLE 4051Cleared 510(K)
- K843073FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP1Cleared 510(K)
- K842390SYVA IQ 190 DIGITAL PIPETTER DILUTER1Cleared 510(K)
- K841043BEHRING ELISA PROCESSOR M1Cleared 510(K)
- K840938HIGH SPEED DISPENSER1Cleared 510(K)
- K834590ACCUFLEX1Cleared 510(K)
- K833959MICROLAB M DILUTER/DISPENSER1Cleared 510(K)
- K833666UR/RITE SYSTEM1Cleared 510(K)
- K833505IL MODEL 840 MICROPROCESSOR LOADER1Cleared 510(K)
- K832809ACCU-PREP PROGRAMMABLE AUTO-DILUTER1Cleared 510(K)
- K832205PRECISION LIQUID DISPENSER1Cleared 510(K)
- K832204MICROLAB P1Cleared 510(K)
- K832202PB 600 REPEATING DISPENSER1Cleared 510(K)
- K831249PRO QUANTUM1Cleared 510(K)
- K831273QST TM SAMPLE PROCESSOR1Cleared 510(K)
- K830319AUTO PREP1Cleared 510(K)
- K830157DIGIFLEX AUTOMATIC PIPETTE1Cleared 510(K)
- K823364COUNT-10 SYSTEM FOR STAND. URINALYSIS1Cleared 510(K)
- K822688DIGITAL DILUTER/DISPENSERS1Cleared 510(K)
- K822208CAVRO IQ-190 SAMPLE PROCESSOR1Cleared 510(K)
- K821034SKATRON REPEATING DISPENSER1Cleared 510(K)
- K821039UNI-PUMP 2001Cleared 510(K)
- K821007ECLIPSE1Cleared 510(K)
- K813426MULTIWASH1Cleared 510(K)
- K812983DSD1Cleared 510(K)
- K812782DISPENSER ASPIRATOR DA 3001Cleared 510(K)
- K812647EMIT AUTO CAROUSEL1Cleared 510(K)
- K811696IL #781, SEMI-AUTOMATED LOADER1Cleared 510(K)
- K811001MICROERMA SYSTEM1Cleared 510(K)
- K810509DIGITAL DISPENSING PUMP1Cleared 510(K)
- K803092MIC-BIOPLATE INOCULATOR1Cleared 510(K)
- K802520CENTRIFICHEM PIPETTOR ACCURACY CALIB.1Cleared 510(K)
- K801913MICROLAB M-MICROPROCESSOR DILUTER/DISP1Cleared 510(K)
- K801851CENTRIFICHEM PIPETTOR 10001Cleared 510(K)
- K801271MODEL 4900 OFF-LINE PREPARATION SYSTEM1Cleared 510(K)
- K801090J.T. BAKER LSA 290 PIPETTER/DILUTER1Cleared 510(K)
- K801030RIAUSE AUTO PROCESSOR1Cleared 510(K)
- K800606MICROMEDIC AUTOMATIC DILUTER1Cleared 510(K)
- K800141ACCUSTROKE PIPET1Cleared 510(K)
- K800075MICROMEDIC PUNCH & ELUTER1Cleared 510(K)
- K791324MICROMEDIC APS21Cleared 510(K)
- K790041ACCESSORY KIT, CENTRIFICHEM1Cleared 510(K)
- K782130MINI-DILUTER 21Cleared 510(K)
- K781883DILUTER, LSA 290 PIPETTER1Cleared 510(K)
- K781645AUTODILUTER 21Cleared 510(K)
- K781646SRD-21Cleared 510(K)
- K780912ADJUSTABLE DISPENSOR1Cleared 510(K)
- K780882DILUTER/DISPENSER1Cleared 510(K)
- K780785DILUTOR TRANSPORTER1Cleared 510(K)
- K780789PERALISTIC PUMP MODEL 20001Cleared 510(K)
- K780208ASPIRATOR, MANUEL1Cleared 510(K)
- K770773PIPETTE, DILUTING, MODEL ADP-30SD1Cleared 510(K)
- K770772PIPETTE, DISPENSING, MODEL ADP-30SD1Cleared 510(K)
- K770307MICRO/PETTOR, SMI1Cleared 510(K)
- K770355PIPETTOR W/DETIPPER1Cleared 510(K)
- K770193PIPETTOR, 400, CENTRIFICHEM SYSTEM1Cleared 510(K)
- K770208MOTORIZED OPERATOR FOR PIPETTING DEV.1Cleared 510(K)
- K761290COMPU-PET 3001Cleared 510(K)
- K770210ANALYTIX AUTO SAMPLE PREP. STA. 16001Cleared 510(K)
- K770013PIPETTING DEVICES1Cleared 510(K)
- 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
DSD
- Page Type
- Cleared 510(K)
- 510(k) Number
- K812983
- 510(k) Type
- Traditional
- Applicant
- PM AMERICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/10/1981
- Days to Decision
- 15 days