510(k) K010523

Device

MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST

Applicant

Binax, Inc.

510(k) number

K010523

Product code

GTZ

Decision

Substantially Equivalent (SESE)

Decision date

2001-03-15

Date received

2001-02-22

Regulation

866.3740

Classification name

Antisera, All Groups, Streptococcus Spp.

Medical specialty

Microbiology

Review panel

Microbiology

Device class

1

Clearance type

Special

Statement or summary

Summary

Third party reviewed

N