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 K902360
Device Name HEMA-SCREEN
Applicant
Immunostics Co., Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Applicant Contact KENNETH KUPITS
Correspondent
Immunostics Co., Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Correspondent Contact KENNETH KUPITS
Regulation Number864.6550
Classification Product Code
KHE  
Date Received05/29/1990
Decision Date 07/27/1990
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
-
-