Wako L-Type Amylase

by Wako Chemicals USA, Inc. 510(k)

Active United States

510(k) K984184

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK984184	Date13 Jan 1999Cleared	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Withdrawn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: K984184
FDA Product Code: JFJ

Device Class: Class II
Regulation: 21 CFR Part 862.1070
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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