Cleared Traditional

K960759 - GONOPOX TEST KIT
(FDA 510(k) Clearance)

K960759 · Medtex Laboratories, Inc. · Microbiology device

Sep 1996

Decision

205d

Days

Class 1

Risk

K960759 is an FDA 510(k) clearance for the GONOPOX TEST KIT. This device is classified as a Kit, Identification, Neisseria Gonorrhoeae (Class I - General Controls, product code JSX).

Submitted by Medtex Laboratories, Inc. (Seattle, US). The FDA issued a Cleared decision on September 18, 1996, 205 days after receiving the submission on February 26, 1996.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K960759 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 26, 1996
Decision Date	September 18, 1996
Days to Decision	205 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement