Cleared Traditional

K141506 - MCC Para-Fix CARY BLAIR MEDIUM

K141506 is an FDA 510(k) clearance for MCC Para-Fix CARY BLAIR MEDIUM, manufactured by Medical Chemical Corporation. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K141506 · Medical Chemical Corporation · Microbiology device
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Feb 2015
Decision
264d
Days
Class 1
Risk

K141506 is an FDA 510(k) clearance for the MCC Para-Fix CARY BLAIR MEDIUM. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Medical Chemical Corporation (Torrance, US). The FDA issued a Cleared decision on February 25, 2015 after a review of 264 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 Medical Chemical Corporation devices

FDA 510(k) Submission Details - K141506

510(k) Number K141506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2014
Decision Date February 25, 2015
Days to Decision 264 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
162d slower than avg
Panel avg: 102d · This submission: 264d
Pathway characteristics
Predicate-based equivalence.

JSM Device Classification - Class 1, General Controls

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.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 77
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K141506.
Puritan Opti-Tranz Cary-Blair Collection and Transport System
K160082 · Puritan Medical Products, LLC · Jul 2016
Para-Fix C&S Medium
K150887 · Medical Chemical Corporation · May 2015
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K142094 · Copan Italia Spa · Apr 2015
Puritan OptiTranz Liquid Stuart Collection and Transport System
K142366 · Puritan Medical Products, LLC · Jan 2015
TRANSPORT CULTURE MEDIUM DEVICE
K113249 · Puritan Medical Products, LLC · Mar 2012
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
K042970 · Copan Diagnostics, Inc. · Dec 2004