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 Antisera, All Groups, Streptococcus Spp.
510(k) Number K952873
Device Name MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
Applicant
Medix Biotech, Inc.
1531 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact DELIA R BETHELL
Correspondent
Medix Biotech, Inc.
1531 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact DELIA R BETHELL
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received06/06/1995
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-