DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

Mycophenolic Acid Test System

SIEMENS HEATLHCARE DIAGNOSTICS INC

The following data is part of a premarket notification filed by Siemens Heatlhcare Diagnostics Inc with the FDA for Dimension Mycophenolic Acid (mpat) Flex Reagent Cartridge, Dimension Mycophenolic Acid Calibrator (mpat Cal).

Pre-market Notification Details

Device IDK102772
510k NumberK102772
Device Name:DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
ClassificationMycophenolic Acid Test System
Applicant SIEMENS HEATLHCARE DIAGNOSTICS INC 500 GBC DRIVE M/S 514 Newark,  DE  19714 -6101
ContactHelen M Lee
CorrespondentHelen M Lee
SIEMENS HEATLHCARE DIAGNOSTICS INC 500 GBC DRIVE M/S 514 Newark,  DE  19714 -6101
Product CodeOAV  
CFR Regulation Number862.3840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-24
Decision Date2011-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768036217 K102772 000
00842768004902 K102772 000

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