Cleared Traditional

K925450 - BIONOR TRANSPORTMEDIUM

K925450 is an FDA 510(k) clearance for BIONOR TRANSPORTMEDIUM, manufactured by Skoug Research Corp.. The device is a Class 1 Microbiology device with product code JSL cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K925450 · Skoug Research Corp. · Microbiology device
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Jun 1993
Decision
240d
Days
Class 1
Risk

K925450 is an FDA 510(k) clearance for the BIONOR TRANSPORTMEDIUM. Classified as Culture Media, Anaerobic Transport (product code JSL), Class I - General Controls.

Submitted by Skoug Research Corp. (Cambridge, US). The FDA issued a Cleared decision on June 25, 1993 after a review of 240 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 Skoug Research Corp. devices

FDA 510(k) Submission Details - K925450

510(k) Number K925450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1992
Decision Date June 25, 1993
Days to Decision 240 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
138d slower than avg
Panel avg: 102d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

JSL Device Classification - Class 1, General Controls

Product Code JSL Culture Media, Anaerobic 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 - JSL Culture Media, Anaerobic Transport

Devices cleared under the same product code (JSL) and FDA review panel - the closest regulatory comparables to K925450.
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
K972448 · Copan Italia Spa · Aug 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K972449 · Copan Italia Spa · Aug 1997
ANAEROBIC TRANSPORT MEDIUM
K841220 · Anaerobe Systems · Apr 1984
ANA TRANS TUBE & SWABS STERILE PACK
K834357 · Anaerobe Systems · Jan 1984
PRE-REDUCED ANAEROBIC MEDIA
K770840 · Gibco Laboratories Life Technologies, Inc. · Jun 1977
PRE-DUCED CULTURE MEDIA
K770650 · Gibco Laboratories Life Technologies, Inc. · Apr 1977