JBAIDS INFLUENZA A&B DETECTION KIT


Device Classification Name

respiratory virus panel nucleic acid assay system

510(k) Number K111775
Device Name JBAIDS INFLUENZA A&B DETECTION KIT
Applicant
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY
1430 veterans drive
fort detrick, 
MD 
21702

Applicant Contact patricia beverly
Correspondent
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY
1430 veterans drive
fort detrick, 
MD 
21702

Correspodent Contact patricia beverly
Regulation Number 866.3980
Classification Product Code
OCC  
Subsequent Product Code
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