Complement Control

by Wako Chemicals USA, Inc. 510(k)

Active United States

510(k) K960874

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK960874	Date14 Jun 1996Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K960874
FDA Product Code: JJX

Device Class: Class I
Regulation: 21 CFR Part 862.1660
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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