Cleared Traditional

K183462 - Applied Biosystems Bacillus anthracis Detection Kit (FDA 510(k) Clearance)

K183462 · Mriglobal · Microbiology device
Oct 2019
Decision
291d
Days
-
Risk

K183462 is an FDA 510(k) clearance for the Applied Biosystems Bacillus anthracis Detection Kit..

Submitted by Mriglobal (Kansas City, US). The FDA issued a Cleared decision on October 1, 2019, 291 days after receiving the submission on December 14, 2018.

This device falls under the Microbiology FDA review panel.

Submission Details

510(k) Number K183462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2018
Decision Date October 01, 2019
Days to Decision 291 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QIF
Device Class -