MYOLEX

Myoglobin, Antigen, Antiserum, Control

ORION CORP.

The following data is part of a premarket notification filed by Orion Corp. with the FDA for Myolex.

Pre-market Notification Details

• Device ID: K863730
• 510k Number: K863730
• Device Name: MYOLEX
• Classification: Myoglobin, Antigen, Antiserum, Control
• Applicant: ORION CORP. P.O. BOX 425 20101 Turku, FI
• Contact: Timo Raines
• Correspondent: Timo Raines; ORION CORP. P.O. BOX 425 20101 Turku, FI
• Product Code: DDR
• CFR Regulation Number: 866.5680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-09-23
• Decision Date: 1986-10-15