Cleared Traditional

K943051 - MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT

K943051 is an FDA 510(k) clearance for MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT, manufactured by Dynagen, Inc.. The device is a Class 1 Microbiology device with product code JSY cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K943051 · Dynagen, Inc. · Microbiology device
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Mar 1995
Decision
259d
Days
Class 1
Risk

K943051 is an FDA 510(k) clearance for the MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT. Classified as Kit, Identification, Mycobacteria (product code JSY), Class I - General Controls.

Submitted by Dynagen, Inc. (Cambridge, US). The FDA issued a Cleared decision on March 13, 1995 after a review of 259 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device framework. 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.

View all Dynagen, Inc. devices

FDA 510(k) Submission Details - K943051

510(k) Number K943051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date March 13, 1995
Days to Decision 259 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 102d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

JSY Device Classification - Class 1, General Controls

Product Code JSY Kit, Identification, Mycobacteria
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.