BD DIRECTIGEN EZ RSV KIT


Device Classification Name

antigen, cf (including cf controls), respiratory syncytial virus

510(k) Number K022133
Device Name BD DIRECTIGEN EZ RSV KIT
Original Applicant
BECTON DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152 -0999

Original Contact colleen a kistler
Regulation Number 866.3480
Classification Product Code
GQG  
Date Received 07/01/2002
Decision Date 12/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls