Clearance Summary
ENZYMATIC TRIGLYCERIDES-S.V.R. received FDA 510(k) clearance under submission number K790773, sponsored by Calbiochem-Behring Corp.. 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 1979-06-15.
- Submission: K790773
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1705
- Decision date: 1979-06-15
Classification & Regulation
This clearance is catalogued under FDA product code CDT and 21 CFR 862.1705, within the Clinical Chemistry review panel as a Class I device.