Cleared Traditional

K924053 - CYTOQUANT COMBINED TRANSPORT MEDIA (FDA 510(k) Clearance)

Class I Microbiology device.

K924053 · Proteins Intl., Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Jan 1993
Decision
156d
Days
Class 1
Risk

K924053 is an FDA 510(k) clearance for the CYTOQUANT COMBINED TRANSPORT MEDIA. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Proteins Intl., Inc. (Rochester Hills, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 156 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Proteins Intl., Inc. devices

Submission Details

510(k) Number K924053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1992
Decision Date January 15, 1993
Days to Decision 156 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 102d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.