Cleared Traditional

K950196 - CULTURE MEDIA

K950196 is the FDA 510(k) clearance for CULTURE MEDIA by Bioclinical Systems, Inc.. It is a Class 2 Microbiology device (product code JTY) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K950196 · Bioclinical Systems, Inc. · Microbiology device
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Jun 1995
Decision
163d
Days
Class 2
Risk

K950196 is an FDA 510(k) clearance for the CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Bioclinical Systems, Inc. (Annapolis Junction, US). The FDA issued a Cleared decision on June 30, 1995 after a review of 163 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2410 - 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 Bioclinical Systems, Inc. devices

Submission Details

510(k) Number K950196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1995
Decision Date June 30, 1995
Days to Decision 163 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
61d slower than avg
Panel avg: 102d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTY Culture Media, For Isolation Of Pathogenic Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2410
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTY Culture Media, For Isolation Of Pathogenic Neisseria

All 47
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