Cleared Traditional

K150887 - Para-Fix C&S Medium

K150887 is an FDA 510(k) clearance for Para-Fix C&S 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 57-day FDA review.

K150887 · Medical Chemical Corporation · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
57d
Days
Class 1
Risk

K150887 is an FDA 510(k) clearance for the Para-Fix C&S 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 May 29, 2015 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Chemical Corporation devices

FDA 510(k) Submission Details - K150887

510(k) Number K150887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2015
Decision Date May 29, 2015
Days to Decision 57 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
45d faster than avg
Panel avg: 102d · This submission: 57d
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
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