Clearance Summary
BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT received FDA 510(k) clearance under submission number K934293, sponsored by Beckman-Diagnostic Systems Group. 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 1994-07-06.
- Submission: K934293
- Applicant / Sponsor: Beckman-Diagnostic Systems Group
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1070
- Decision date: 1994-07-06
Classification & Regulation
This clearance is catalogued under FDA product code JFJ and 21 CFR 862.1070, within the Clinical Chemistry review panel as a Class II device.