Clearance Summary
LACTATE DEHYDROGENASE (LDH-L) received FDA 510(k) clearance under submission number K880630, sponsored by Tech-Co, 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 1988-03-16.
- Submission: K880630
- Applicant / Sponsor: Tech-Co, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1440
- Decision date: 1988-03-16
Classification & Regulation
This clearance is catalogued under FDA product code CFH and 21 CFR 862.1440, within the Clinical Chemistry review panel as a Class II device.