Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201

by Wako Chemicals USA, Inc. 510(k)

Active United States

510(k) K080123

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK080123	Date17 Jul 2008Cleared	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Withdrawn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: K080123
FDA Product Code: CFR
Models / Variants: 993-24601
991-24401
993-25201

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

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