Wako(Tm) Autokit Ldh

by Wako Chemicals USA, Inc. 510(k)

Active United States

510(k) K870401

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK870401	Date6 Mar 1987Cleared	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Withdrawn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: K870401
FDA Product Code: CFJ

Device Class: Class II
Regulation: 21 CFR Part 862.1440
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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