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 K060463
Device Name HEMA SCREEN SPECIFIC IFOBT
Applicant
Immunostics Inc.,
3505 Sunset Ave.
Ocean,  NJ  07712
Applicant Contact JEFFREY FLEISHMAN
Correspondent
Immunostics Inc.,
3505 Sunset Ave.
Ocean,  NJ  07712
Correspondent Contact JEFFREY FLEISHMAN
Regulation Number864.6550
Classification Product Code
KHE  
Date Received02/22/2006
Decision Date 06/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-