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, Neutralization, Influenza Virus A, B, C
510(k) Number K984596
Device Name VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
Applicant
Zymetx, Inc.
800 Research Pkwy., Suite 100
Oklahoma City,  OK  73104
Applicant Contact CRAIG D SHIMASAKI
Correspondent
Zymetx, Inc.
800 Research Pkwy., Suite 100
Oklahoma City,  OK  73104
Correspondent Contact CRAIG D SHIMASAKI
Regulation Number866.3330
Classification Product Code
GNR  
Date Received12/28/1998
Decision Date 03/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-