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 Hexokinase, Glucose
510(k) Number K860625
Device Name GLUCOSE HK-60 ASSAY KIT CAT. #201-39
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
CFR  
Date Received02/19/1986
Decision Date 03/17/1986
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
-
-