Cleared Traditional

KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS

K861022 · Micro-Bio-Logics · Microbiology
Apr 1986
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K861022 is an FDA 510(k) clearance for the KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS, a Kit, Quality Control For Culture Media (Class I — General Controls, product code JTR), submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on April 4, 1986, 17 days after receiving the submission on March 18, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2480.

Submission Details

510(k) Number K861022 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1986
Decision Date April 04, 1986
Days to Decision 17 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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