Cleared Traditional

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

K183462 · Mriglobal · Microbiology device
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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 after a review of 291 days - an extended review cycle.

This device falls under the Microbiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 102d · This submission: 291d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QIF
Device Class -

Regulatory Consultant

MDC Associates, LLC
Fran White

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.