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 K914877
Device Name IL TEST(TM) UREA NITROGEN
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
P.O. BOX 9113
LEXINGTON,  MA  02173
Applicant Contact GEORGE A LYNA
Correspondent
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
P.O. BOX 9113
LEXINGTON,  MA  02173
Correspondent Contact GEORGE A LYNA
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received10/29/1991
Decision Date 03/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-