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, Radioallergosorbent (Rast) Immunological
510(k) Number K934524
Device Name MAST CLA ALLERGY SYSTEM
Applicant
Mast Immunosystems
630 Clyde Ct.
Mountain View,  CA  94043
Applicant Contact CHRISTOPHER BROWN
Correspondent
Mast Immunosystems
630 Clyde Ct.
Mountain View,  CA  94043
Correspondent Contact CHRISTOPHER BROWN
Regulation Number866.5750
Classification Product Code
DHB  
Date Received09/20/1993
Decision Date 03/07/1994
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
-
-