Cleared Traditional

K943498 - KULTSURE STARSWAB (M210), MODIFICATION

K943498 is an FDA 510(k) clearance for KULTSURE STARSWAB (M210), manufactured by Ncs Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K943498 · Ncs Diagnostics, Inc. · Microbiology device
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Nov 1994
Decision
170d
Days
Class 1
Risk

K943498 is an FDA 510(k) clearance for the KULTSURE STARSWAB (M210), MODIFICATION. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Ncs Diagnostics, Inc. (Etobicoke, Ontario, CA). The FDA issued a Cleared decision on November 30, 1994 after a review of 170 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 Ncs Diagnostics, Inc. devices

FDA 510(k) Submission Details - K943498

510(k) Number K943498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1994
Decision Date November 30, 1994
Days to Decision 170 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
68d slower than avg
Panel avg: 102d · This submission: 170d
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 78
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K943498.
10B ARGININE BROTH
K961046 · Remel, L.P. · Sep 1996
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K962843 · Starplex Scientific, Inc. · Sep 1996
CVM TRANSPORT
K955451 · Hardy Diagnostics · Jul 1996
FLEXTRANS
K935987 · Baxter Diagnostics, Inc. · Aug 1994
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
BACTI-SWAB
K910180 · Remel Co. · May 1991