Clearance Summary
LACTATE DEHYDROGENASE LDH received FDA 510(k) clearance under submission number K883206, sponsored by Electro-Nucleonics, 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 1988-09-09.
- Submission: K883206
- Applicant / Sponsor: Electro-Nucleonics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1440
- Decision date: 1988-09-09
Classification & Regulation
This clearance is catalogued under FDA product code CFJ and 21 CFR 862.1440, within the Clinical Chemistry review panel as a Class II device.