Cleared Traditional

ELVI BICLOT 816

K812906 · Volu Sol Medical Industries · Hematology
Jul 1982
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K812906 is an FDA 510(k) clearance for the ELVI BICLOT 816, a Instrument, Coagulation (Class II — Special Controls, product code KQG), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982, 276 days after receiving the submission on October 19, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K812906 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1981
Decision Date July 22, 1982
Days to Decision 276 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KQG — Instrument, Coagulation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5400

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