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SPQ Antibody Reagent Set II for C4

by Atlantic Antibodies 510(k)

Active United States

510(k) K890564

Overview

The SPQ Antibody Reagent Set II for C4 is a diagnostic in vitro device used for the detection and measurement of Complement C4 antigen, antiserum, and controls. It falls under the classification of Complement C4-related reagents, designed for immunology applications in laboratory settings.

This set is intended for single-use in clinical laboratories and has received FDA 510(k) clearance under the product code DBI (regulation number 866.5240) with a decision of Substantially Equivalent. Supplied as a reagent kit, it is regulated under the Immunology specialty and requires adherence to standard laboratory practices for handling and storage. The device was cleared in 1989 and remains compliant with FDA requirements for diagnostic use.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890564 Date17 Feb 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Spq(Tm) Antibody Reagent Set Ii for C4
510(k) Number
FDA Product Code
DBI
Device Class
Class II
Regulation
21 CFR Part 866.5240
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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