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Complement C3 Nephelometric Assay

by J.T. Baker Chemical Co. 510(k)

Active United States

510(k) K801363

Overview

This device is a complement C3 nephelometric assay, used for the quantitative measurement of complement C3 antigen in clinical specimens. It employs nephelometry to detect antigen-antibody complexes formed between complement C3 and specific antisera.

The assay is supplied as a reagent system for in vitro diagnostic use in immunology testing. It is intended for use in clinical laboratory settings and has been cleared under FDA 510(k) submission K801363, with product code CZW and regulation number 866.5240.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801363 Date30 Jun 1980ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CZW
Device Class
Class II
Regulation
21 CFR Part 866.5240
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Complement C3 Nephelometric Assay used for?

    It is used for the quantitative measurement of complement C3 antigen in clinical specimens, detecting antigen-antibody complexes formed between complement C3 and specific antisera via nephelometry.

  • How is the Complement C3 Nephelometric Assay supplied and intended for use?

    It is supplied as a reagent system for in vitro diagnostic use in immunology testing and is intended for use in clinical laboratory settings.

  • What regulatory pathway was used for the Complement C3 Nephelometric Assay?

    The device was cleared under the FDA 510(k) process, specifically submission K801363, and is classified as substantially equivalent to a legally marketed device.