Cleared Traditional

MYOLEX

K863730 · Orion Corp. · Immunology
Oct 1986
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K863730 is an FDA 510(k) clearance for the MYOLEX, a Myoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDR), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on October 15, 1986, 22 days after receiving the submission on September 23, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5680.

Submission Details

510(k) Number K863730 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1986
Decision Date October 15, 1986
Days to Decision 22 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DDR — Myoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5680

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