Cleared Traditional

K860657 - KULTSURE (CATALOGUE NO. M240)

K860657 is the FDA 510(k) clearance for KULTSURE (CATALOGUE NO. M240) by Ncs Diagnostics, Inc.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K860657 · Ncs Diagnostics, Inc. · Microbiology device
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Mar 1986
Decision
11d
Days
Class 1
Risk

K860657 is an FDA 510(k) clearance for the KULTSURE (CATALOGUE NO. M240). Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Ncs Diagnostics, Inc. (Mississauga, L4z 1y6, CA). The FDA issued a Cleared decision on March 4, 1986 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 Ncs Diagnostics, Inc. devices

Submission Details

510(k) Number K860657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1986
Decision Date March 04, 1986
Days to Decision 11 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
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 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 53
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K860657.
BUFFERED GLYCEROL SALINE
K863602 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
CARY-BLAIR TRANSPORT MEDIUM
K863527 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)
K861080 · Difco Laboratories, Inc. · Apr 1986
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU
K854986 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1986
TRANSPORT CULTURE MEDIA
K854715 · Hillcrest Biologicals · Dec 1985
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM
K854061 · Syva Co. · Oct 1985