• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name everolimus immunoassay
510(k) Number K122766
Model 0380000, 0380005, 0380010
Device Name THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
Original Applicant
MICROGENICS CORP.
46360 fremont blvd
fremont,  CA  94538
Original Contact karen lee
Regulation Number862.3840
Classification Product Code
OUF  
Date Received09/10/2012
Decision Date 08/20/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-