Cleared Traditional

MICRORING YT

K900112 · Medical Wire & Equipment Co. · Microbiology
Jul 1990
Decision
203d
Days
Class 1
Risk

About This 510(k) Submission

K900112 is an FDA 510(k) clearance for the MICRORING YT, a Kit, Identification, Yeast (Class I — General Controls, product code JXB), submitted by Medical Wire & Equipment Co. (Fairview Park, US). The FDA issued a Cleared decision on July 31, 1990, 203 days after receiving the submission on January 9, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K900112 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1990
Decision Date July 31, 1990
Days to Decision 203 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JXB — Kit, Identification, Yeast
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660