510(k) K093784

Device

ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM

Applicant

ZEUS SCIENTIFIC, INC.

510(k) number

K093784

Product code

OPM  

Decision

Substantially Equivalent (SESE)

Decision date

2010-07-16

Date received

2009-12-09

Regulation

866.3510

Classification name

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No