Clearance Summary
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 received FDA 510(k) clearance under submission number K080123, sponsored by Wako Chemicals USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2008-07-17.
- Submission: K080123
- Applicant / Sponsor: Wako Chemicals USA, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2008-07-17
Classification & Regulation
This clearance is catalogued under FDA product code CFR and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.