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510(k) K102772

Device
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
Applicant
SIEMENS HEATLHCARE DIAGNOSTICS INC
510(k) number
K102772
Product code
OAV  
Decision
Substantially Equivalent (SESE)
Decision date
2011-10-07
Date received
2010-09-24
Regulation
862.3840
Classification name
Mycophenolic Acid Test System
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HELEN M LEE
Address
500 Gbc Dr., M/S 514 Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OAV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081083CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLSThermo Fisher Scientific2008-12-19
K063520ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLSRoche Diagnostics2007-02-16

Legacy Summary#

summary

FDA Review#

Decision Summary