Turbiquant Myoglobin

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K903687 ↗

FDA Product Code

DDR

Device Class

Class II

Regulation

21 CFR Part 866.5680

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• N/T Rheumatology Control Sl/1 and Sl/2

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  FDA 510(k) K962373 Active Cleared 11 Jul 1996

See all devices from Behring Diagnostics, Inc. →

• What is the primary use of the Turbiquant Myoglobin device?

  The Turbiquant Myoglobin device is designed for use in immunological testing procedures. It functions as a myoglobin antigen, antiserum, and control to support diagnostic laboratory analysis.

• What is the regulatory classification of this device?

  Turbiquant Myoglobin is classified as a Class II medical device. It has received FDA 510(k) clearance under regulation number 866.5680, which pertains to myoglobin antigen, antiserum, and control products.

• Who is the manufacturer of the Turbiquant Myoglobin?

  The device is manufactured by Behring Diagnostics, Inc., located in Somerville, New Jersey. The product was cleared for use following a traditional 510(k) submission process.