Cleared Traditional

KULTSURE STARSWAB (M210), MODIFICATION

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

About This 510(k) Submission

K943498 is an FDA 510(k) clearance for the KULTSURE STARSWAB (M210), MODIFICATION, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Ncs Diagnostics, Inc. (Etobicoke, Ontario, CA). The FDA issued a Cleared decision on November 30, 1994, 170 days after receiving the submission on June 13, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K943498 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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