Cleared Traditional

K961755 - CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM (FDA 510(k) Clearance)

Class I Microbiology device.

K961755 · Proteins Intl., Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
11d
Days
Class 1
Risk

K961755 is an FDA 510(k) clearance for the CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM. Classified as Culture Media, Propagating Transport (product code JSN), Class I - General Controls.

Submitted by Proteins Intl., Inc. (Rochester Hills, US). The FDA issued a Cleared decision on May 17, 1996 after a review of 11 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 Proteins Intl., Inc. devices

Submission Details

510(k) Number K961755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1996
Decision Date May 17, 1996
Days to Decision 11 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
91d faster than avg
Panel avg: 102d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSN Culture Media, 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.