SAS RSV TEST


Device Classification Name

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

510(k) Number K022845
Device Name SAS RSV TEST
Original Applicant
SA SCIENTIFIC, INC.
4919 golden quail
san antonio, 
TX 
78240

Original Contact ricardo r martinez
Regulation Number 866.3480
Classification Product Code
GQG  
Date Received 08/27/2002
Decision Date 01/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No