QUICKLAB RSV


Device Classification Name

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

510(k) Number K021789
Device Name QUICKLAB RSV
Original Applicant
INTEGRATED BIOTECHNOLOGY CORP.
366 ridgepoint dr.
carmel, 
IN 
46032

Original Contact sally a booth
Regulation Number 866.3480
Classification Product Code
GQG  
Date Received 05/31/2002
Decision Date 11/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No