Wako Autokit Glucose

by Wako Chemicals USA, Inc. 510(k)

Active United States

510(k) K950172

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK950172	Date5 Oct 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Withdrawn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)

510(k) Number: K950172
FDA Product Code: CGA

Device Class: Class II
Regulation: 21 CFR Part 862.1345
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

Other devices from Wako Chemicals USA, Inc.

Wako Direct Bilirubin V

Class II
Wako Autokit CH50

Class II
Wako Total Bilirubin V

Class II
Wako Nefa Linearity Set

Class I
Total Bilirubin Standard Calibrator

Class II
Wako Autokit Apo A1

Class I

See all devices from Wako Chemicals USA, Inc. →