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LEH — Radioimmunoassay, Vancomycin Class II

FDA Device Classification

Classification Details

Product Code
LEH
Device Class
Class II
Regulation Number
862.3950
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222439siemens healthcare diagnosticsAtellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)August 8, 2023
K160202siemens healthcare diagnosticsTrinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)April 27, 2016
K152245roche diagnostics operations (rdo)ONLINE TDM Vancomycin Gen.3January 8, 2016
K123947biokitARCHITECT IVANCOMYCINAugust 29, 2013
K072036biokitARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1PMarch 19, 2008
K063045diagnostic productsIMMULITE 2000, IMMULITE 2500 VANCOMYCINDecember 5, 2006
K060586roche diagnosticsENZYME IMMUNOASSAY, VANCOMYCINMay 11, 2006
K050419seradynQMS VANCOMYCINApril 1, 2005
K043386ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VEFebruary 7, 2005
K032811microgenicsCEDIA VANCOMYCIN ASSAYNovember 24, 2003
K020692dade behringEMIT 2000 VANCOMYCIN ASSAYMay 10, 2002
K013076beckman coulterSYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATORDecember 12, 2001
K983280diagnostic reagentsVANCOMYCIN EIA ASSAYNovember 6, 1998
K964587bayerVANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEMJanuary 13, 1997
K963267dade intlVANCOMYCIN FLEX REAGENT CARTRIDGESeptember 13, 1996
K955851abbott laboratoriesAXSYM VANCOMYCIN IIMay 9, 1996
K955716sigma diagnosticsVANCOMYCIN FPIA REAGENT SETFebruary 16, 1996
K953528roche diagnostic systemsROCHE COBAS-FP REAGENTS FOR VANCOMYCINSeptember 12, 1995
K951059ciba corning diagnosticsCIBA CORNING ACS VANCOMYCIN IMMUNOASSAYJune 19, 1995
K945125du pontDUPONT ACA VANCOMYCIN (VANC) METHODMarch 10, 1995