DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)— 510(k) K102772

Name: FDA 510(k) clearance K102772
Creator: U.S. Food and Drug Administration
Published: 2011-10-07

Substantially Equivalent

Siemens Heatlhcare Diagnostics, Inc.

FDA 510(k) clearance K102772 for DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL), Substantially Equivalent on 2011-10-07. Applicant: Siemens Heatlhcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Heatlhcare Diagnostics, Inc.
Product code: Code OAV
Device class: Class 2
Regulation: 21 CFR 862.3840
Advisory panel: Clinical Toxicology
Date received: 2010-09-24
Decision date: 2011-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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