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 Glucose Oxidase, Glucose
510(k) Number K875211
Device Name GLUCOSE (TRINDER) CAT. # 220-32
Applicant
Diagnostic Chemicals, Ltd. (Usa)
435 Main St.
Monroe,  CT  06468
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
435 Main St.
Monroe,  CT  06468
Correspondent Contact KAREN CALLBECK
Regulation Number862.1345
Classification Product Code
CGA  
Date Received12/18/1987
Decision Date 04/18/1988
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
-
-