510(k) K040407

Device

QUICKELISA ANTHRAX-PA KIT

Applicant

IMMUNETICS, INC.

510(k) number

K040407

Product code

NRL  

Decision

Substantially Equivalent (SESE)

Decision date

2004-06-03

Date received

2004-02-17

Regulation

866.3045

Classification name

Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No