JBAIDS INFLUENZA A SUBTYPING KIT


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

Correspodent Contact patricia m beverly
Regulation Number 866.3332
Classification Product Code
OQW  
Subsequent Product Codes
OEP   OOI  
Date Received 06/23/2011
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