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 Assay, 1,5-Anhydroglucitol (15ag)
510(k) Number K031604
Device Name GLYCOMARK
Applicant
Tomen America, Inc.
1285 Ave. Of The Americas
New York,  NY  10019
Applicant Contact Erika B Ammirati
Correspondent
Tomen America, Inc.
1285 Ave. Of The Americas
New York,  NY  10019
Correspondent Contact Erika B Ammirati
Regulation Number864.7470
Classification Product Code
NOZ  
Subsequent Product Codes
JIS   JJX  
Date Received05/22/2003
Decision Date 09/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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
-
-