Cleared Traditional

K943050 - MYCOAKT M KANSASII CULTURE ID KIT (FDA 510(k) Clearance)

Class I Microbiology device.

K943050 · Dynagen, Inc. · Microbiology device
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Mar 1995
Decision
259d
Days
Class 1
Risk

K943050 is an FDA 510(k) clearance for the MYCOAKT M KANSASII CULTURE 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

Submission Details

510(k) Number K943050 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.

Device Classification

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.