510(k) K030370

Device

REDLINE ANTHRAX ALERT TEST

Applicant

TETRACORE, INC

510(k) number

K030370

Product code

NPO  

Decision

Substantially Equivalent (SESE)

Decision date

2003-12-09

Date received

2003-02-04

Regulation

866.3045

Classification name

Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No