Wako Autokit CH50

by Wako Chemicals USA, Inc. United States 510(k)

510(k) K954145 Product code DAE

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK954145	Date18 Dec 1995Cleared	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Withdrawn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) · synced 22 Oct 2026

510(k) Number: K954145
FDA Product Code: DAE

Device Class: Class II
Regulation: 21 CFR Part 866.5240
Advisory Committee: Immunology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K954145 24 fields · synced 22 Oct 2026