Cleared Traditional

LYFO-KWIK (TM) COAGULASE PLASMA

K861312 · Micro-Bio-Logics · Hematology
Apr 1986
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K861312 is an FDA 510(k) clearance for the LYFO-KWIK (TM) COAGULASE PLASMA, a Plasma, Coagulase, Human, Horse And Rabbit (Class I — General Controls, product code JTL), submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on April 18, 1986, 10 days after receiving the submission on April 8, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 866.2160.

Submission Details

510(k) Number K861312 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1986
Decision Date April 18, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JTL — Plasma, Coagulase, Human, Horse And Rabbit
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2160

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