Clearance Summary
CBC PAP TEST KIT received FDA 510(k) clearance under submission number K802153, sponsored by Calbiochem-Behring Corp.. 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 1980-11-12.
- Submission: K802153
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1020
- Decision date: 1980-11-12
Classification & Regulation
This clearance is catalogued under FDA product code JFH and 21 CFR 862.1020, within the Clinical Chemistry review panel as a Class II device.