Cleared Traditional

LYFO-DISK MICROORGANISMS

K842129 · Micro-Bio-Logics · Microbiology
Jul 1984
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K842129 is an FDA 510(k) clearance for the LYFO-DISK MICROORGANISMS, a Kit, Quality Control For Culture Media (Class I — General Controls, product code JTR), submitted by Micro-Bio-Logics (Mchenry, US). The FDA issued a Cleared decision on July 3, 1984, 35 days after receiving the submission on May 29, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2480.

Submission Details

510(k) Number K842129 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1984
Decision Date July 03, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTR — Kit, Quality Control For Culture Media
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2480

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