Clearance Summary
PHOSPHORUS (INORGANIC) received FDA 510(k) clearance under submission number K881171, sponsored by Tech-Co, 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 1988-04-28.
- Submission: K881171
- Applicant / Sponsor: Tech-Co, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1580
- Decision date: 1988-04-28
Classification & Regulation
This clearance is catalogued under FDA product code CEO and 21 CFR 862.1580, within the Clinical Chemistry review panel as a Class I device.