Wako(Tm) Autokit Total Protein

by Wako Chemicals USA, Inc. 510(k)

Active United States

510(k) K880312

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK880312	Date24 Mar 1988Cleared	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Withdrawn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: K880312
FDA Product Code: CEK

Device Class: Class II
Regulation: 21 CFR Part 862.1635
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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