Atlas FDA

AXSYM VANCOMYCIN II

FDA 510(k) clearance K955851 · decided 1996-05-09

Clearance details

K-number
K955851
Device name
AXSYM VANCOMYCIN II
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1995-12-27
Decision date
1996-05-09
Days to decision
134 days
Clearance type
Traditional
Product code
LEH
Device class
2
Regulation number
862.3950
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30