Clearance Summary
CALIBRATOR, BOVINE SERUM received FDA 510(k) clearance under submission number K781702, 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 1978-11-15.
- Submission: K781702
- Applicant / Sponsor: Bio-Reagents & Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 1978-11-15
Classification & Regulation
This clearance is catalogued under FDA product code JIX and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.