Cleared Traditional

K944847 - KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM

K944847 is an FDA 510(k) clearance for KULTSURE/STARSWAB ANAEROBIC TRANSPORT S..., manufactured by Starplex Scientific, Inc.. The device is a Class 1 Microbiology device with product code JSL cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K944847 · Starplex Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
139d
Days
Class 1
Risk

K944847 is an FDA 510(k) clearance for the KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM. Classified as Culture Media, Anaerobic Transport (product code JSL), Class I - General Controls.

Submitted by Starplex Scientific, Inc. (Etobicoke, Ontario, CA). The FDA issued a Cleared decision on February 16, 1995 after a review of 139 days - within the typical 510(k) review window.

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 Starplex Scientific, Inc. devices

FDA 510(k) Submission Details - K944847

510(k) Number K944847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1994
Decision Date February 16, 1995
Days to Decision 139 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
37d slower than avg
Panel avg: 102d · This submission: 139d
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 K944847.
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