Kallestad's Endoplate Factor B Test

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

510(k) Number

K811740 ↗

FDA Product Code

JZH

Device Class

Class II

Regulation

21 CFR Part 866.5320

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Kallestad Laboratories, Inc. →

• What is Kallestad's Endoplate Factor B Test used for?

  Kallestad's Endoplate Factor B Test is used to detect Factor B antigen in immunology testing, functioning as an antigen, antiserum, and control device for laboratory analysis of the alternative complement pathway.

• How is Kallestad's Endoplate Factor B Test supplied and what is its regulatory classification?

  The device is supplied as a Factor B, Antigen, Antiserum, Control kit for immunology use and is classified as a Class II medical device under FDA regulation 866.5320, having received traditional 510(k) clearance as substantially equivalent to a predicate device.

• When was Kallestad's Endoplate Factor B Test cleared by the FDA and under what submission number?

  Kallestad's Endoplate Factor B Test received FDA 510(k) clearance on July 16, 1981, under submission number K811740, following a traditional review process after being received on June 19, 1981.