Clearance Summary
ALPCO/MERCODIA INSULIN ELISA received FDA 510(k) clearance under submission number K963911, sponsored by American Laboratory Products Co., Ltd.. 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 1996-11-01.
- Submission: K963911
- Applicant / Sponsor: American Laboratory Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1405
- Decision date: 1996-11-01
Classification & Regulation
This clearance is catalogued under FDA product code CFP and 21 CFR 862.1405, within the Clinical Chemistry review panel as a Class I device.