Cleared Traditional

LYFO KWIK(TM) RUS KIT

K870731 · Micro-Bio-Logics · Microbiology
Jun 1987
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K870731 is an FDA 510(k) clearance for the LYFO KWIK(TM) RUS KIT, a Kit, Screening, Urine (Class I — General Controls, product code JXA), submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on June 17, 1987, 112 days after receiving the submission on February 25, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K870731 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1987
Decision Date June 17, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JXA — Kit, Screening, Urine
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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