BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK


Device Classification Name

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

510(k) Number K021646
Device Name BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
Original Applicant
BINAX, INC.
217 read st.
portland, 
ME 
04103

Original Contact anne jepson
Regulation Number 866.3330
Classification Product Code
GNX  
Date Received 05/20/2002
Decision Date 09/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No