Clearance Summary
PROJECT 300 MICROASSAY BP-12, EIA MINILAB received FDA 510(k) clearance under submission number K873451, sponsored by Awareness Technology, 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 1987-11-04.
- Submission: K873451
- Applicant / Sponsor: Awareness Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1987-11-04
Classification & Regulation
This clearance is catalogued under FDA product code JJQ and 21 CFR 862.2300, within the Clinical Chemistry review panel as a Class I device.