Clearance Summary
CPK ISOENZYME CONTROL received FDA 510(k) clearance under submission number K770555, 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 1977-06-03.
- Submission: K770555
- Applicant / Sponsor: Bio-Reagents & Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1977-06-03
Classification & Regulation
This clearance is catalogued under FDA product code JJT and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.