FLU OIA A/B TEST KIT


Device Classification Name

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

510(k) Number K023556
Device Name FLU OIA A/B TEST KIT
Original Applicant
THERMO BIOSTAR, INC.
331 south 104 st.
louisville, 
CO 
80027

Original Contact john g adams
Regulation Number 866.3330
Classification Product Code
GNX  
Date Received 10/23/2002
Decision Date 03/27/2003
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