Clearance Summary
LDH ISOENZYME CONTROL received FDA 510(k) clearance under submission number K771894, sponsored by Bio-Reagents & Diagnostics, 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 1977-12-22.
- Submission: K771894
- Applicant / Sponsor: Bio-Reagents & Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1445
- Decision date: 1977-12-22
Classification & Regulation
This clearance is catalogued under FDA product code CEX and 21 CFR 862.1445, within the Clinical Chemistry review panel as a Class II device.