Wako Autokit Lipase-Color

by Wako Chemicals USA, Inc. 510(k)

Active United States

510(k) K921249

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK921249	Date21 Jul 1992Cleared	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Withdrawn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: K921249
FDA Product Code: CHI

Device Class: Class I
Regulation: 21 CFR Part 862.1465
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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