Cleared Traditional

K871404 - KULTSURE
(FDA 510(k) Clearance)

K871404 · Ncs Diagnostics, Inc. · Microbiology

Apr 1987

Decision

13d

Days

Class 1

Risk

K871404 is an FDA 510(k) clearance for the KULTSURE. 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 21, 1987, 13 days after receiving the submission on April 8, 1987.

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

Submission Details

510(k) Number	K871404 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 1987
Decision Date	April 21, 1987
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—