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 Calibrators, Drug Mixture
510(k) Number K033879
Device Name VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
Applicant
Maine Standards Co.
765 Roosevelt Trail
Suite 9a
Windham,  ME  04062 -5365
Applicant Contact CHRISTINE BEACH
Correspondent
Maine Standards Co.
765 Roosevelt Trail
Suite 9a
Windham,  ME  04062 -5365
Correspondent Contact CHRISTINE BEACH
Regulation Number862.3200
Classification Product Code
DKB  
Date Received12/15/2003
Decision Date 02/27/2004
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
Predetermined Change
Control Plan Authorized		 No
-
-