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 K110880
Device Name VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
Applicant
Maine Standards Company, LLC
765 Roosevelt Trl.
Windham,  ME  04062
Applicant Contact HOLLY CRESSMAN
Correspondent
Maine Standards Company, LLC
765 Roosevelt Trl.
Windham,  ME  04062
Correspondent Contact HOLLY CRESSMAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/30/2011
Decision Date 07/05/2011
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
-
-