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 Reagent, Occult Blood
510(k) Number K901064
Device Name MONOHAEM (FECAL OCCULT BLOOD TEST)
Applicant
Silenus Laboratories Proprietary , Ltd.
Wilmington,  DE  19897
Applicant Contact WILLIAM A BEST
Correspondent
Silenus Laboratories Proprietary , Ltd.
Wilmington,  DE  19897
Correspondent Contact WILLIAM A BEST
Regulation Number864.6550
Classification Product Code
KHE  
Date Received03/07/1990
Decision Date 11/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-