Immunoglobulins M

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K873871 ↗

FDA Product Code

DFT

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Clearblue Easy

  Class II

  FDA 510(k) K911566 Active Cleared 6 May 1991

• Immunoglobulins G

  Class II

  FDA 510(k) K873870 Active Cleared 13 Oct 1987

• Cefepine Antimicrobial Susceptibility Test Disc

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  FDA 510(k) K964495 Active Cleared 7 Feb 1997

• Turbox Fibrinogen

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  FDA 510(k) K884179 Active Cleared 20 Dec 1988

• Clearblue Easy Earliest Results Pregnancy Test

  Class II

  FDA 510(k) K040341 Active Cleared 8 Mar 2004

• Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

  Class II

  FDA 510(k) K913305 Active Cleared 22 Nov 1991

See all devices from Unipath, Ltd. →

• What are Immunoglobulins M used for in laboratory settings?

  Immunoglobulins M are laboratory reagents used in immunology testing as antibodies that serve as antigens, antisera, or controls in diagnostic procedures. They are essential components for various immunological assays and tests.

• How is the Immunoglobulins M device supplied and is it single-use or reusable?

  The device is supplied as a laboratory reagent. The description does not specify whether it is single-use or reusable, indicating that its usage may depend on laboratory protocols and specific testing requirements.

• What regulatory approvals does the Immunoglobulins M device have?

  The Immunoglobulins M device has FDA 510(k) clearance with product code DFT. It is classified as substantially equivalent and is MRI safe. The device is manufactured by Unipath, Ltd. and has multiple registration numbers.

• Are there different sizes or models of the Immunoglobulins M device available?

  The device data does not specify different sizes or models of the Immunoglobulins M. It is described as a laboratory reagent with multiple registration numbers, suggesting variations in packaging or formulation rather than distinct models.