RSV OIA


Device Classification Name

antisera, cf, poliovirus 1-3

510(k) Number K021172
Device Name RSV OIA
Original Applicant
THERMO BIOSTAR, INC.
6655 lookout rd.
boulder, 
CO 
80301

Original Contact kohn g adams
Regulation Number 866.3405
Classification Product Code
GOG  
Date Received 04/12/2002
Decision Date 09/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No