Anesthesiology
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- CardiovascularReview Panel
- ChemistryReview Panel
- 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
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- DJREnzyme Immunoassay, Methadone2Product Code
- PFTReagents For Molecular Diagnostic Test Systems1Product Code
- QKTClozapine Test System2Product Code
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method2Product Code
- DIDBacillus Subtilis Microbiology Assay, Tobramycin2Product Code
- DIEHeavy Metals Control Materials1Product Code
- DIFDrug Mixture Control Materials1Product Code
- DIGCholinesterase Test Paper1Product Code
- DIHColorimetry, Cholinesterase1Product Code
- DIJLead, Delta Amino Levulinic Acid2Product Code
- DIKThin Layer Chromatography, Quinine1Product Code
- DILRadioimmunoassay, Primidone2Product Code
- DIMGas Chromatography, Salicylate2Product Code
- DINGas Chromatography, Cocaine2Product Code
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites2Product Code
- DIPEnzyme Immunoassay, Diphenylhydantoin2Product Code
- DIQRadioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.2Product Code
- DIRFree Radical Assay, Cocaine2Product Code
- DISEnzyme Immunoassay, Barbiturate2Product Code
- DITThin Layer Chromatography, Amphetamine2Product Code
- DIWHemagglutination Inhibition, Methadone2Product Code
- DIXThin Layer Chromatography, Phenobarbital2Product Code
- DIYGas Chromatography, Ethosuximide2Product Code
- DIZDelayed Analysis, Alcohol2Product Code
- DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.2Product Code
- DJCThin Layer Chromatography, Methamphetamine2Product Code
- DJDEnzyme Immunoassay, Primidone2Product Code
- DJEThin Layer Chromatography, Salicylate2Product Code
- DJFGas Chromatography, Opiates2Product Code
- DJGEnzyme Immunoassay, Opiates2Product Code
- DJHGas Chromatography, Phenobarbital2Product Code
- DJIAntiserum, Gentamicin2Product Code
- DJJFluorometry, Morphine2Product Code
- DJKDigitoxin Control Serum, Ria1Product Code
- DJLFree Radical Assay, Amphetamine2Product Code
- DJNMercury Dithiazone, Colorimetry, Barbiturate2Product Code
- DJPRadioimmunoassay, Amphetamine2Product Code
- DJQTest Reagents For Phenothiazine2Product Code
- DJXRadioimmunoassay, Ethosuximide2Product Code
- DJZDevices, Breath Trapping, Alcohol1Product Code
- DKAAntiserum, Digoxin2Product Code
- DKBCalibrators, Drug Mixture2Product Code
- DKCAlcohol Control Materials1Product Code
- DKDBacillus Subtilis, Microbiological Assay, Gentamicin2Product Code
- DKEReagents, Test, Tetrahydrocannabinol2Product Code
- DKHGas Chromatography, Diphenylhydantoin2Product Code
- DKJColorimetry, Salicylate2Product Code
- DKNRadioimmunoassay, Barbiturate2Product Code
- DKPRadioimmunoassay, Phenobarbital2Product Code
- DKQAntiserum, Digitoxin2Product Code
- DKRThin Layer Chromatography, Methadone2Product Code
- DKTFree Radical Assay, Opiates2Product Code
- DKWTest Reagents For Sulphanimide Derivatives1Product Code
- DKXThin Layer Chromatography, Barbiturate2Product Code
- DKZEnzyme Immunoassay, Amphetamine2Product Code
- DLATest Reagents For Methyl Alcohol2Product Code
- DLBRadioimmunoassay, Lsd (125-I)2Product Code
- DLDThin Layer Chromatography, Codeine2Product Code
- DLEReagents, Test, Bromides2Product Code
- DLFEnzyme Immunoassay, Ethosuximide2Product Code
- DLHGas Chromatography, Alcohol2Product Code
- DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase1Product Code
- DLJCalibrators, Drug Specific2Product Code
- K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 22Cleared 510(K)
- K091617QMS LIDOCAINE CALIBRATORS, MODEL 03746782Cleared 510(K)
- K082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC4402Cleared 510(K)
- K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC5202Cleared 510(K)
- K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)2Cleared 510(K)
- K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)2Cleared 510(K)
- K060503DIMENSION TACR CALIBRATOR, MODEL DC1072Cleared 510(K)
- K053108DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC1082Cleared 510(K)
- K052015DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC1082Cleared 510(K)
- K033601LABONE MICRO-PLATE COTININE EIA2Cleared 510(K)
- K033246PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS2Cleared 510(K)
- K033165PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS2Cleared 510(K)
- K023780DRI PRIMIDONE CALIBRATORS2Cleared 510(K)
- K023316SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS2Cleared 510(K)
- K021449CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS2Cleared 510(K)
- K020845EMIT 2000 VANCOMYCIN CALIBRATORS2Cleared 510(K)
- K020769SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS2Cleared 510(K)
- K012109DRI ECSTASY URINE CALIBRATORS2Cleared 510(K)
- K011112CYCLOSPORINE CALIBRATOR2Cleared 510(K)
- K993473SYNCHRON SYSTEMS DRUG CALIBRATOR 22Cleared 510(K)
- K993022SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS2Cleared 510(K)
- K983556ABUSCREEN ONLINE BENZ 300 CALIBRATORS2Cleared 510(K)
- K983555ABUSCREEN ONLINE BENZ 200 CALIBRATORS2Cleared 510(K)
- K981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS2Cleared 510(K)
- K973536ACE PHENOBARBITAL REAGENT/AED CALIBRATORS2Cleared 510(K)
- K97283550NG/ML COCAINE METABOLITE CALIBRATOR2Cleared 510(K)
- K972433CEDIA DIGOXIN CALIBRATORS2Cleared 510(K)
- K970509INNOFLOUR CALIBRATOR REAGENT SET2Cleared 510(K)
- K962280ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR2Cleared 510(K)
- K961726ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 202Cleared 510(K)
- K940048STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION2Cleared 510(K)
- K955813CEDIA DAU LSD CALBIRATORS2Cleared 510(K)
- K951153CEDIA DAU PPX/METH CALIBRATOR2Cleared 510(K)
- K945338THEOPHYLLINE CALIBRATORS2Cleared 510(K)
- K945316PHENOBARBITAL CALIBRATORS2Cleared 510(K)
- K945337PHENYTOIN CALIBRATORS2Cleared 510(K)
- K935795CEDIA DAU THC CALIBRATORS2Cleared 510(K)
- K932548ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS2Cleared 510(K)
- K934144DUPONT ACA URINE METHADONE CALIBRATOR2Cleared 510(K)
- K933279ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR2Cleared 510(K)
- K931506URINE CALIBRATOR AND CONTROL2Cleared 510(K)
- K923386THC URINE CALIBRATORS2Cleared 510(K)
- K920749THC URINE CALIBRATORS2Cleared 510(K)
- K915464DIGITOXIN FPIA CALIBRATOR SET2Cleared 510(K)
- K913186INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET2Cleared 510(K)
- K912048ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS2Cleared 510(K)
- K911466INNOFLUOR VALPROIC ACID CALIBRATOR SET2Cleared 510(K)
- K910086ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS2Cleared 510(K)
- K904569EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS2Cleared 510(K)
- K904307DUPONT SALICYLATE CALIBRATOR2Cleared 510(K)
- K904303DUPONT DRUG CLIBRATOR-B2Cleared 510(K)
- K904308DUPONT ALCOHOL CALIBRATOR2Cleared 510(K)
- K903101INNOFLUOR (TM) AMIKACIN CALIBRATOR SET2Cleared 510(K)
- K895826INNOFLUOR DIGOXIN CALIBRATOR SET2Cleared 510(K)
- K895572N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT2Cleared 510(K)
- K895570VALPROIC ACID (FPIA) CALIBRATOR KIT2Cleared 510(K)
- K895568PRIMIDONE (FPIA) CALIBRATOR KIT2Cleared 510(K)
- K894522FPR DIGOXIN CALIBRATOR KIT2Cleared 510(K)
- K894530FPR THEOPHYLLINE CALIBRATOR KIT2Cleared 510(K)
- K894532FPR TOBRAMYCIN CALIBRATOR KIT2Cleared 510(K)
- K894520FPR CARBAMAZEPINE CALIBRATOR KIT2Cleared 510(K)
- K894526FPR PHENOBARBITAL CALIBRATOR KIT2Cleared 510(K)
- K893506INNOFLUOR CARBAMAZEPINE CALIBRATOR SET2Cleared 510(K)
- K892212INNOFLUOR(TM) QUINDINE CALIBATOR SET2Cleared 510(K)
- K892901ACA VANCOMYCIN CALIBRATOR2Cleared 510(K)
- K890452EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR2Cleared 510(K)
- K890451EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR2Cleared 510(K)
- K884745DU PONT ACA METHOTREXATE CALIBRATOR2Cleared 510(K)
- K884170ANALYST THEOPHYLLINE CALIBRATOR2Cleared 510(K)
- K883920EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A2Cleared 510(K)
- K881337EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/952Cleared 510(K)
- K875135EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL2Cleared 510(K)
- K874101EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/952Cleared 510(K)
- K874102EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/952Cleared 510(K)
- K873436EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/952Cleared 510(K)
- K873281CARBAMAZEPINE (FPIA) CALIBRATOR KIT2Cleared 510(K)
- K872644INNOFLUOR VANCOMYCIN CALIBRATOR SET2Cleared 510(K)
- K872461INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET2Cleared 510(K)
- K872463INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET2Cleared 510(K)
- K872462INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET2Cleared 510(K)
- K872181ETHANOL CALIBRATOR2Cleared 510(K)
- K872349INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET2Cleared 510(K)
- K872142INNOFLUOR PHENYTOIN CALIBRATOR SET2Cleared 510(K)
- K872328DIGOXIN FPIA CALIBRATORS2Cleared 510(K)
- K871423PHENYTOIN FPIA CALIBRATORS2Cleared 510(K)
- K871394THEOPHYLLINE FPIA CALIBRATORS2Cleared 510(K)
- K871330EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/952Cleared 510(K)
- K870390PHENOBARBITAL (FPIA) CALIBRATOR KIT2Cleared 510(K)
- K870389DIGOXIN (FPIA) CALIBRATOR KIT2Cleared 510(K)
- K870247EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/932Cleared 510(K)
- K863244AMIKACIN (FPIA) CALIBRATOR KIT2Cleared 510(K)
- K862964ANTIASTHMATIC CALIBRATORS2Cleared 510(K)
- K861395EMIT COLUMN DIGOXIN CALIBRATORS2Cleared 510(K)
- K850457DU PONT DIGOXIN ASSAY CALIBRATOR2Cleared 510(K)
- K850057DU PONT TOBRAMYCIN ASSAY CALIBRATOR2Cleared 510(K)
- K850059DU PONT GENTAMICIN ASSAY CALIBRATOR2Cleared 510(K)
- K843420EMIT 700 CANNABINOID CALIBRATOR2Cleared 510(K)
- K843210AMIKACIN CALIBRATOR ACA2Cleared 510(K)
- K834457EMIT D.A.U. URINE CANNABINOID CALIBRA2Cleared 510(K)
- K841655DUPONT THEOPHYLLINE DIT CALIBRATOR2Cleared 510(K)
- K841108ACA DIGOXIN CALLIBRATOR2Cleared 510(K)
- K840597QUINIDINE CALIBRATOR2Cleared 510(K)
- K833977SERALYZER DRUG ASSAY CONTROL SERUM2Cleared 510(K)
- K833382VALPROIC ACID CALIBRATOR2Cleared 510(K)
- K833383PROCAINAMIDE CALIBRATOR2Cleared 510(K)
- K833380LIDOAINE CALIBRATOR2Cleared 510(K)
- K832982ACA TOBRAMYCIN CALIBRATOR2Cleared 510(K)
- K831980EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA2Cleared 510(K)
- K831933THEOPHYLLINE ACA CALIBRATOR2Cleared 510(K)
- K831209GENTAMICIN CALIBRATOR -ACA2Cleared 510(K)
- K822587ADVANCE EMIT-CAD QUINIDINE CONTROL2Cleared 510(K)
- K822052EMIT D.A.V. METHAQUALONE URINE CALIBRA2Cleared 510(K)
- K812197EMIT-ST CANNABINOID CALIBRATOR2Cleared 510(K)
- K811622EMIT-ST SERUM PHENOBARBITAL CALIBRATOR2Cleared 510(K)
- K800247EMIT -D.A.U. CANNABINOID URINE CALIBS.2Cleared 510(K)
- K790399URINE MEDIUM CALIBRATOR2Cleared 510(K)
- K790398EMIT-D.A.U. PHENCYCLIDINE URINE LOW2Cleared 510(K)
- K780731LIDOCAINE CALIBRATOR KIT2Cleared 510(K)
- K780732PROCAINAMIDE CALIBRATOR KIT2Cleared 510(K)
- K772167EMIT LIDOCAINE CONTROL2Cleared 510(K)
- K772166EMIT THEOPHYLLINE CONTROL2Cleared 510(K)
- K771805ACA SALICYLATE CALIBRATOR2Cleared 510(K)
- K771799ACA ALCOHOL CALIBRATORS2Cleared 510(K)
- DLNHemagglutination, Cocaine Metabolites (Benzoylecgnonine)2Product Code
- DLPRadioimmunoassay, Diphenylhydantoin2Product Code
- DLRHemagglutination Inhibition, Morphine2Product Code
- DLSGas Chromatograph, Alcohol (Dedicated Instruments)2Product Code
- DLTHemagglutination, Opiates2Product Code
- DLXHemagglutination Inhibition, Barbiturate2Product Code
- DLZEnzyme Immunoassay, Phenobarbital2Product Code
- DMBGas Chromatography, Methadone2Product Code
- DMFGas Liquid Chromatography, Barbiturate2Product Code
- DMIPotassium Dichromate Specific Reagent For Alcohol2Product Code
- DMJTest Reagents For Ethyl Alcohol2Product Code
- DMKLead, Protoporphyrin, Fluorometric2Product Code
- DMLNad-Nadh, Specific Reagent For Alcohol Enzyme Method2Product Code
- DMNThin Layer Chromatography, Cocaine2Product Code
- DMPDigoxin Control Serum, Ria1Product Code
- DMQGas Chromatography, Primidone2Product Code
- DMRSolution, M-Nitrophenol, Specific Reagent For Cholinesterase1Product Code
- DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet2Product Code
- DMXLiquid Chromatography, Salicylate2Product Code
- DMYGas Chromatography, Morphine2Product Code
- DNARadioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody2Product Code
- DNCStrip, Paper, Salicylate2Product Code
- DNDRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.2Product Code
- DNEAtomic Absorption, Antimony1Product Code
- DNFLiquid Chromatography, Ethosuximide2Product Code
- DNGFree Radical, Benzoylecgnonine2Product Code
- DNILiquid Chromatography, Amphetamine2Product Code
- DNJRadioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.2Product Code
- DNKThin Layer Chromatography, Morphine2Product Code
- DNLRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.2Product Code
- DNNCalibrators, Ethyl Alcohol2Product Code
- DNOHemagglutination Inhibition, Gentamicin2Product Code
- DNPThin Layer Chromatography, Ethosuximide2Product Code
- DNQRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.2Product Code
- DNSRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.2Product Code
- DNTLiquid Chromatography, Methadone2Product Code
- DNWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.2Product Code
- DNXLead, Protoporphyrin Zinc Method, Fluorometric2Product Code
- DNZAtomic Absorption, Arsenic1Product Code
- DOARadioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.2Product Code
- DOBRadioimmunoassay, Digitoxin (3-H)2Product Code
- DODGas Chromatography, Amphetamine2Product Code
- DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.2Product Code
- DOFLead, Atomic Absorption2Product Code
- DOGRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol2Product Code
- DOHElectrometry, Cholinesterase1Product Code
- DOJPotassium Dichromate, Alcohol2Product Code
- DOKFree Radical Assay, Morphine2Product Code
- DOLFree Radical Assay, Lsd2Product Code
- DOMThin Layer Chromatography, Benzoylecgnonine2Product Code
- DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.2Product Code
- DOOLiquid Chromatography, Phenobarbital2Product Code
- DORRadioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.2Product Code
- DOSThin Layer Chromatography, Primidone2Product Code
- DOWRadioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube2Product Code
- DOXFluorometer, Lead (Dedicated Instruments)2Product Code
- DOYRadioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.2Product Code
- DOZLiquid Chromatography, Diphenylhydantoin2Product Code
- DPBRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.2Product Code
- DPDRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.2Product Code
- DPEThin Layer Chromatography, Diphenylhydantoin2Product Code
- DPGRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.2Product Code
- DPHMercury, Atomic Absorption1Product Code
- DPIRadioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.2Product Code
- DPJRadioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.2Product Code
- DPKLiquid Chromatography, Morphine2Product Code
- DPLRadioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.2Product Code
- DPNThin Layer Chromatography, Propoxyphene2Product Code
- DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.2Product Code
- DPPFree Radical Assay, Methadone2Product Code
- DPQLiquid Chromatography, Primidone2Product Code
- JIHFlame Photometry, Lithium2Product Code
- JIIAtomic Absorption, Lithium2Product Code
- JKQGold Chloride (Colorimetric), Bromide2Product Code
- JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide1Product Code
- JKTGas Chromatograph, Carbon-Monoxide1Product Code
- JXMEnzyme Immunoassay, Benzodiazepine2Product Code
- JXNEnzyme Immunoassay, Propoxyphene2Product Code
- JXOEnzyme Immunoassay, Cocaine2Product Code
- KJIRadioimmunoassay, Kanamycin2Product Code
- KLBRadioimmunoassay, Tobramycin2Product Code
- KLNRadioimmunoassay, Cocaine Metabolite2Product Code
- KLOEnzymatic Radiochemical Assay, Gentamicin2Product Code
- KLPAmikacin Serum Assay2Product Code
- KLQRadioimmunoassay, Amikacin2Product Code
- KLREnzyme Immunoassay, Lidocaine2Product Code
- KLSEnzyme Immunoassay, Theophylline2Product Code
- KLTEnzyme Immunoassay, Carbamazepine2Product Code
- KXSRadioimmunoassay, Methaqualone2Product Code
- KXTEnzyme Immunoassay, Digoxin2Product Code
- KZTKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin2Product Code
- KZWKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin2Product Code
- KZXKit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin2Product Code
- KZYHigh Pressure Liquid Chromatography, Barbiturate2Product Code
- KZZGas Chromatography, Benzodiazepine2Product Code
- LAAHigh Pressure Liquid Chromatography, Benzodiazepine2Product Code
- LABThin Layer Chromatography, Benzodiazepine2Product Code
- LACHigh Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites2Product Code
- LADGas Chromatography, Codeine2Product Code
- LAEHigh Pressure Liquid Chromatography, Codeine2Product Code
- LAFGas Chromatography, Methamphetamine2Product Code
- LAGHigh Pressure Liquid Chromatography, Methamphetamine2Product Code
- LAHHigh Pressure Liquid Chromatography, Opiates2Product Code
- LAIThin Layer Chromatography, Opiates2Product Code
- LAJGas Chromatography, Propoxyphene2Product Code
- LAKHigh Pressure Liquid Chromatography, Propoxyphene2Product Code
- LALEas Chromatography, Quinine1Product Code
- LAMHigh Pressure Liquid Chromatography, Quinine1Product Code
- LANEnzyme Immunoassay, N-Acetylprocainamide2Product Code
- LAREnzyme Immunoassay, Procainamide2Product Code
- LASDrug Specific Control Materials1Product Code
- LATRadioimmunoassay, Cannabinoid(S)2Product Code
- LAWTheophylline Control Materials1Product Code
- LAXLidocaine Control Materials1Product Code
- LAYMethotrexate Control Materials1Product Code
- LAZN-Acetylprocainamide Control Materials1Product Code
- LBAProcainamide Control Materials1Product Code
- LBZEnzyme Immunoassay, Quinidine2Product Code
- LCARadioimmunoassay, Theophylline2Product Code
- LCDEnzyme Immunoassay, Gentamicin2Product Code
- LCERadioimmunoassay, Netilmicin (I-125)2Product Code
- LCQFluorescent Immunoassay Gentamicin2Product Code
- LCRFluorescent Immunoassay, Tobramycin2Product Code
- LCSRadioimmunoassay, Digoxin (125-I)2Product Code
- LCTRadioimmunoassay, Digoxin (3-H)2Product Code
- LCWRadioimmunoassay, Digitoxin (125-I)2Product Code
- LCYU.V. Spectrometry, Theophylline2Product Code
- LCZU.V. Spectrometry, Primidone2Product Code
- LDAU.V. Spectrometry, Phenobarbital2Product Code
- LDBU.V. Spectrometry, Carbamazepine2Product Code
- LDCU.V. Spectrometry, Diphenylhydantoin2Product Code
- LDJEnzyme Immunoassay, Cannabinoids2Product Code
- LDNEnzymatic Radiochemical Assay, Amikacin2Product Code
- LDOEnzymatic Radiochemical Assay, Tobramycin2Product Code
- LDPColorimetry, Acetaminophen2Product Code
- LEGEnzyme Immunoassay, Valproic Acid2Product Code
- LEHRadioimmunoassay, Vancomycin2Product Code
- LERFluorescent Immunoassay, Theophylline2Product Code
- LESFluorescent Immunoassay, Diphenylhydantoin2Product Code
- LETFluorescent Immunoassay, Phenobarbital2Product Code
- LEWThin Layer Chromatography, Theophylline2Product Code
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs2Product Code
- LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs2Product Code
- LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs2Product Code
- LFMEnzyme Immunoassay, Digitoxin2Product Code
- LFNNephelometric Inhibition Immunoassay, Phenobarbital2Product Code
- LFONephelometric Inhibition Immunoassay, Diphenylhydantoin2Product Code
- LFTFluorescent Immunoassay, Primidone2Product Code
- LFWFluorescence Polarization Immunoassay, Tobramycin2Product Code
- LGIFluorescence Polarization Immunoassay, Carbamazepine2Product Code
- LGJFluorescence Polarization Immunoassay, Amibacin2Product Code
- LGQFluorescence Polarization Immunoassay, Phenobarbital2Product Code
- LGRFluorescence Polarization Immunoassay, Diphenylhydantoin (Total)2Product Code
- LGSFluorescence Polarization Immunoassay, Theophylline2Product Code
- LPXRadioceptor Assay, Neuroleptic Drugs2Product Code
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites1Product Code
- MLKThin Layer Chromatography, Tricyclic Antidepressant Drugs2Product Code
- MOJFluorescence Polarization Immunoassay, Diphenylhydantoin (Free)2Product Code
- MRSTest System, Nicotine, Cotinine, Metabolites1Product Code
- MSLSystem, Test, Topiramatee2Product Code
- NDWAssay, Porphyrin, Spectrophotometry, Lithium2Product Code
- NFTTest, Amphetamine, Over The Counter2Product Code
- NFVTest, Benzodiazepine, Over The Counter2Product Code
- NFWTest, Cannabinoid, Over The Counter2Product Code
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter2Product Code
- NGGTest, Methamphetamine, Over The Counter2Product Code
- NGITest, Morphine, Over The Counter2Product Code
- NGLTest, Opiates, Over The Counter2Product Code
- NRPSirolimus Test System2Product Code
- NTIDrug Metabolizing Enzyme Genotyping Systems2Product Code
- NWMImmunoassay, Anti-Seizure Drug2Product Code
- OAVMycophenolic Acid Test System2Product Code
- ODWCytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System2Product Code
- OIWSoftware, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types2Product Code
- ORABreast Milk-Alcohol Test System2Product Code
- ORHLamotrigine Assay2Product Code
- ORILevetiracetam Assay2Product Code
- OTFGabapentin Assay2Product Code
- OUFEverolimus Immunoassay2Product Code
- PDYOrganophosphate Test System2Product Code
- POXEnzyme Immunoassay, Oxcarbazepine Metabolite2Product Code
- PTGTest, Methadone, Over The Counter2Product Code
- PTHTest, Barbiturate, Over The Counter2Product Code
- PUJVoriconazole Test System2Product Code
- PUXTest, Amphetamine, Employment And Insurance Testing, Exempt2Product Code
- PUYTest, Barbiturate, Employment And Insurance Testing, Exempt2Product Code
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt2Product Code
- PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt2Product Code
- PVBTest, Codeine, Employment And Insurance Testing, Exempt2Product Code
- PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt2Product Code
- PVETest, Methadone, Employment And Insurance Testing, Exempt2Product Code
- PVFTest, Methaqualone, Employment And Insurance Testing, Exempt2Product Code
- PVGTest, Morphine, Employment And Insurance Testing, Exempt2Product Code
- PVHTest, Opiates, Employment And Insurance Testing, Exempt2Product Code
- PVITest, Propoxyphene, Employment And Insurance Testing, Exempt2Product Code
- PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt2Product Code
- PVKTest, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt2Product Code
- QAWTest, Tricyclic Antidepressants, Over The Counter2Product Code
- QBFTest, Propoxyphene, Over The Counter2Product Code
- QBKMeprobamate Test System2Product Code
- QDRPlazomicin Test System, Immunoassay2Product Code
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Medical GeneticsReview Panel
- UnknownReview Panel
FPR CARBAMAZEPINE CALIBRATOR KIT
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K894520
- 510(k) Type
- Traditional
- Applicant
- COLONY LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/28/1989
- Days to Decision
- 39 days