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 Automated Occult Blood Analyzer
510(k) Number K163225
Device Name AFIAS iFOB with AFIAS-50
Applicant
Immunostics Inc.,
1750 Brielle Ave. A5
Ocean,  NJ  07712
Applicant Contact Antoinette Prusik
Correspondent
Immunostics Inc.,
1750 Brielle Ave. A5
Ocean,  NJ  07712
Correspondent Contact Antoinette Prusik
Regulation Number864.6550
Classification Product Code
OOX  
Subsequent Product Code
JJX  
Date Received11/17/2016
Decision Date 08/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-