Wako Autokit Apo A1

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

510(k) K952615 Product code JHN

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK952615	Date8 Sep 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Withdrawn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: K952615
FDA Product Code: JHN

Device Class: Class I
Regulation: 21 CFR Part 862.1475
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K952615 24 fields · synced 22 Oct 2026