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 K012649
Device Name RAICHEM BUN RATE REAGENT
Applicant
HEMAGEN DIAGNOSTICS, INC.
9033 RED BRANCH RD.
COLUMBIA,  MD  21045
Applicant Contact JOSE A MONTANEZ
Correspondent
HEMAGEN DIAGNOSTICS, INC.
9033 RED BRANCH RD.
COLUMBIA,  MD  21045
Correspondent Contact JOSE A MONTANEZ
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received08/13/2001
Decision Date 10/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-