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 Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K841648
Device Name DIAGEM DIGITAL BLOOD GLUCOSE MONITOR
Applicant
Forward Medical Supplies
222 Emann Dr.
Camillus,  NY  13031
Applicant Contact WILLARD FORWARD
Correspondent
Forward Medical Supplies
222 Emann Dr.
Camillus,  NY  13031
Correspondent Contact WILLARD FORWARD
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received04/20/1984
Decision Date 10/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-