Immunoglobulin M Nephel. Assay

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K772254 ↗

FDA Product Code

DFT

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Kallestad Laboratories, Inc. →

• What is the IMMUNOGLOBULIN M NEPHEL. ASSAY used for?

  This device is used for the quantitative measurement of immunoglobulin M (IgM) in human serum. It is intended for use in clinical laboratory settings within the immunology specialty to support diagnostic testing.

• How was the IMMUNOGLOBULIN M NEPHEL. ASSAY authorized for marketing?

  The assay was cleared through the FDA 510(k) pathway under submission K772254 on December 22, 1977, as substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under regulation 866.5550.

• Who manufactures the IMMUNOGLOBULIN M NEPHEL. ASSAY and where are they located?

  The device is manufactured by Kallestad Laboratories, Inc., located at 4221 Richmond Rd., NW, Walker, MI 49534, United States. This information is part of the establishment registration and device listing data.