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 Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
510(k) Number K874863
Device Name RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
Applicant
Monoclonal Antibodies, Inc.
995 Benicia
Sunnyvale,  CA  94086
Applicant Contact GRIFFIN FITZGERALD
Correspondent
Monoclonal Antibodies, Inc.
995 Benicia
Sunnyvale,  CA  94086
Correspondent Contact GRIFFIN FITZGERALD
Regulation Number866.3305
Classification Product Code
GQN  
Date Received11/25/1987
Decision Date 02/16/1988
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
-
-