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, photometric, urea nitrogen
510(k) Number K822154
Device Name UREA NITROGEN (ENZYMATIC) DETERMINATION
Applicant
THE DOW CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE DOW CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1770
Classification Product Code
CDN  
Date Received07/23/1982
Decision Date 08/05/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-