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 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
510(k) Number K111778
Device Name JBAIDS INFLUENZA A SUBTYPING KIT
Applicant
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY
1430 VETERANS DRIVE
FORT DETRICK,  MD  21702
Applicant Contact PATRICIA M BEVERLY
Correspondent
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY
1430 VETERANS DRIVE
FORT DETRICK,  MD  21702
Correspondent Contact PATRICIA M BEVERLY
Regulation Number866.3332
Classification Product Code
OQW  
Subsequent Product Codes
OEP   OOI  
Date Received06/23/2011
Decision Date 09/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-