Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 multi-analyte controls, all kinds (assayed)
510(k) Number K061196
Device Name CARDIOIMMUNE XL CARDIAC MARKER CONTROL
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT,  CA  94538
Applicant Contact SCOTT HUNTSMAN
Correspondent
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT,  CA  94538
Correspondent Contact SCOTT HUNTSMAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/28/2006
Decision Date 05/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-