Cleared Traditional

NIZYME TEST KIT

K923566 · Remel Co. · Microbiology
Nov 1992
Decision
108d
Days
Class 1
Risk

About This 510(k) Submission

K923566 is an FDA 510(k) clearance for the NIZYME TEST KIT, a Kit, Identification, Neisseria Gonorrhoeae (Class I — General Controls, product code JSX), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on November 2, 1992, 108 days after receiving the submission on July 17, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K923566 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1992
Decision Date November 02, 1992
Days to Decision 108 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JSX — Kit, Identification, Neisseria Gonorrhoeae
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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