510(k) K183462

Device

Applied Biosystems Bacillus Anthracis Detection Kit

Applicant

MRIGlobal

510(k) number

K183462

Product code

QIF

Decision

Substantially Equivalent (SESE)

Decision date

2019-10-01

Date received

2018-12-14

Regulation

510(k) Premarket Notification

Classification name

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

Medical specialty

Immunology

Review panel

Microbiology

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No