• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name enzyme immunoassay, cocaine and cocaine metabolites
510(k) Number K101742
Device Name THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
Applicant
MICROGENICS CORP.
46360 fremont blvd
fremont,  CA  94538
Applicant Contact lisa charter
Correspondent
MICROGENICS CORP.
46360 fremont blvd
fremont,  CA  94538
Correspondent Contact lisa charter
Regulation Number862.3250
Classification Product Code
DIO  
Date Received06/22/2010
Decision Date 04/08/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-