Cleared Traditional

SPECIMEN TRANSPORT MEDIUM (K935618) - FDA 510(k) Clearance

Class I Microbiology device.

K935618 · Biowhittaker Molecular Applications, Inc. · Microbiology device
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Apr 1994
Decision
150d
Days
Class 1
Risk

K935618 is an FDA 510(k) clearance for the SPECIMEN TRANSPORT MEDIUM. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Biowhittaker Molecular Applications, Inc. (Walkersville, US). The FDA issued a Cleared decision on April 21, 1994 after a review of 150 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Biowhittaker Molecular Applications, Inc. devices

Submission Details

510(k) Number K935618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1993
Decision Date April 21, 1994
Days to Decision 150 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
48d slower than avg
Panel avg: 102d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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.

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