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 System, Test, Anticardiolipin Immunological
510(k) Number K932225
Device Name ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM
Applicant
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Applicant Contact ERIC HOY
Correspondent
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Correspondent Contact ERIC HOY
Regulation Number866.5660
Classification Product Code
MID  
Date Received05/07/1993
Decision Date 07/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-