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 urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K860716
Device Name ENZYMATIC BUN REAGENT
Applicant
TRACE SCIENTIFIC LTD.
10 TREFOREST DR.
CLAYTON, VIC 3168,  AU
Applicant Contact RIDDLE
Correspondent
TRACE SCIENTIFIC LTD.
10 TREFOREST DR.
CLAYTON, VIC 3168,  AU
Correspondent Contact RIDDLE
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received02/26/1986
Decision Date 04/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-