Clearance Summary
SPECIFIC CHEMISTRY ANALYZER received FDA 510(k) clearance under submission number K882081, sponsored by The Rupp & Bowman Co.. 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 1988-07-01.
- Submission: K882081
- Applicant / Sponsor: The Rupp & Bowman Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 1988-07-01
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.