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 Test, Cystatin C
510(k) Number K080662
Device Name GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
Applicant
Genzyme Corporation
31 New York Ave.
Framingham,  MA  01701
Applicant Contact ERIC LAWSON
Correspondent
Genzyme Corporation
31 New York Ave.
Framingham,  MA  01701
Correspondent Contact ERIC LAWSON
Regulation Number862.1225
Classification Product Code
NDY  
Subsequent Product Code
JIT  
Date Received03/10/2008
Decision Date 05/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-