BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B


Device Classification Name

antigens, cf (including cf control), influenza virus a, b, c

510(k) Number K112277
Device Name BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
Applicant
Becton, Dickinson and Company
10865 road to the cure,
suite 200
san diego, 
CA 
92064

Applicant Contact gregory p payne
Correspondent
Becton, Dickinson and Company
10865 road to the cure,
suite 200
san diego, 
CA 
92064

Correspodent Contact gregory p payne
Regulation Number 866.3330
Classification Product Code
GNX  
Date Received 08/09/2011
Decision Date 10/28/2011
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