Who is the manufacturer of RANDOX MYOGLOBIN?

Randox Laboratories, Ltd. submitted the Traditional clearance for RANDOX MYOGLOBIN (K010700).

What is the FDA product code for RANDOX MYOGLOBIN?

DDR. It is classified under 21 CFR 866.5680 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for RANDOX MYOGLOBIN?

510(k) clearance (submission type: Traditional).

RANDOX MYOGLOBIN

K010700 · Randox Laboratories, Ltd. · DDR · May 8, 2001 · Immunology

Device Facts

Record ID	K010700
Device Name	RANDOX MYOGLOBIN
Applicant	Randox Laboratories, Ltd.
Product Code	DDR · Immunology
Decision Date	May 8, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5680
Device Class	Class 2

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.