Clearance Summary
UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD received FDA 510(k) clearance under submission number K980525, sponsored by Marukin Shoyu Co., Ltd.. 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 1998-04-15.
- Submission: K980525
- Applicant / Sponsor: Marukin Shoyu Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1187
- Decision date: 1998-04-15
Classification & Regulation
This clearance is catalogued under FDA product code KWX and 21 CFR 862.1187, within the Clinical Chemistry review panel as a Class II device.