Clearance Summary
GASTRIN EIA MODEL 06B-555017 received FDA 510(k) clearance under submission number K961276, sponsored by Biosyn , 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 1996-05-30.
- Submission: K961276
- Applicant / Sponsor: Biosyn , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1325
- Decision date: 1996-05-30
Classification & Regulation
This clearance is catalogued under FDA product code CGC and 21 CFR 862.1325, within the Clinical Chemistry review panel as a Class I device.