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 berthelot indophenol, urea nitrogen
510(k) Number K781899
Device Name UREA NITROGEN TEST
Applicant
WAKO INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
WAKO INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1770
Classification Product Code
CDL  
Date Received11/13/1978
Decision Date 12/20/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-