Cleared Traditional

INDI KWIK (TM) CO/TWO KIT

K855198 · Micro-Bio-Logics · Microbiology
Jan 1986
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K855198 is an FDA 510(k) clearance for the INDI KWIK (TM) CO/TWO KIT, 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 January 14, 1986, 18 days after receiving the submission on December 27, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2480.

Submission Details

510(k) Number K855198 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1985
Decision Date January 14, 1986
Days to Decision 18 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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