BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK


Device Classification Name

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

510(k) Number K021687
Device Name BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
Original Applicant
BINAX, INC.
217 read st.
portland, 
ME 
04103

Original Contact anne jepson
Regulation Number 866.3480
Classification Product Code
GQG  
Date Received 05/22/2002
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