Atlas FDA

LEH

31 FDA 510(k) clearances · Product code

65 daysmedian time to decision
151 days90th percentile
31clearances measured

FDA profile

Official device name
Radioimmunoassay, Vancomycin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3950
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 26 · 2016: 10 · 2017: 15 · 2018: 17 · 2019: 13 · 2020: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (K222439)Siemens Healthcare Diagnostics, Inc.2023-08-08
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (K160202)Siemens Healthcare Diagnostics, Inc.2016-04-27
ONLINE TDM Vancomycin Gen.3 (K152245)Roche Diagnostics Operations (Rdo)2016-01-08
ARCHITECT IVANCOMYCIN (K123947)Biokit, S.A.2013-08-29
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 (K072036)Biokit, S.A.2008-03-19
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (K063045)Diagnostic Products Corp.2006-12-05
ENZYME IMMUNOASSAY, VANCOMYCIN (K060586)Roche Diagnostics Corp.2006-05-11
QMS VANCOMYCIN (K050419)Seradyn, Inc.2005-04-01
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043386)Ortho-Clinical Diagnostics, Inc.2005-02-07
CEDIA VANCOMYCIN ASSAY (K032811)Microgenics Corp.2003-11-24
EMIT 2000 VANCOMYCIN ASSAY (K020692)Dade Behring, Inc.2002-05-10
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR (K013076)Beckman Coulter, Inc.2001-12-12
VANCOMYCIN EIA ASSAY (K983280)Diagnostic Reagents, Inc.1998-11-06
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM (K964587)Bayer Corp.1997-01-13
VANCOMYCIN FLEX REAGENT CARTRIDGE (K963267)Dade Intl., Inc.1996-09-13
AXSYM VANCOMYCIN II (K955851)Abbott Laboratories1996-05-09
VANCOMYCIN FPIA REAGENT SET (K955716)Sigma Diagnostics, Inc.1996-02-16
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN (K953528)Roche Diagnostic Systems, Inc.1995-09-12
CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY (K951059)Ciba Corning Diagnostics Corp.1995-06-19
DUPONT ACA VANCOMYCIN (VANC) METHOD (K945125)The DU Pont Co.1995-03-10
AXSYM VANCOMYCIN (K940595)Abbott Laboratories1994-06-21
OPUS(R) VANCOMYCIN (K924957)Pb Diagnostic Systems, Inc.1992-12-11
COBAS-FP REAGENTS FOR VANCOMYCIN (K901759)Roche Diagnostic Systems, Inc.1990-05-02
MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR (K900708)Innotron of Oregon, Inc.1990-04-19
ACA VANCOMYCIN (VANC) METHOD (K892900)E.I. Dupont DE Nemours & Co., Inc.1989-05-22
EMIT VANCOMYCIN ASSAY (K881040)Syva Co.1988-04-19
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY (K874438)Baxter Healthcare Corp1988-01-21
INNOFLUOR VANCOMYCIN REAGENT SET (K872579)Innotron of Oregon, Inc.1987-08-17
VANCOMYCIN FLUORESCENT IMMUNOASSAY (K822308)American Diagnostic Corp.1982-08-16
TDX TM STREPTOMYCIN (K821136)Abbott Laboratories1982-05-13
TDX VANCOMYCIN (K813218)Abbott Laboratories1981-12-08

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Every clearance here is in the API, with alerts when new ones post.