Cleared Traditional

K860178 - KULTSURE (CULTURE TRANSPORT)
(FDA 510(k) Clearance)

K860178 · Ncs Diagnostics, Inc. · Microbiology

Apr 1986

Decision

77d

Days

Class 1

Risk

K860178 is an FDA 510(k) clearance for the KULTSURE (CULTURE TRANSPORT). This device is classified as a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM).

Submitted by Ncs Diagnostics, Inc. (Mississauga, L4z 1y6, CA). The FDA issued a Cleared decision on April 4, 1986, 77 days after receiving the submission on January 17, 1986.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number	K860178 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 1986
Decision Date	April 04, 1986
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—