Clearance Summary
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 received FDA 510(k) clearance under submission number K963934, sponsored by Bio-Rad Laboratories, 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 1996-12-16.
- Submission: K963934
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1996-12-16
Classification & Regulation
This clearance is catalogued under FDA product code MMI and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.