Clearance Summary
BETA-HCG ASSAY received FDA 510(k) clearance under submission number K873986, sponsored by Schiff & 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 1988-02-02.
- Submission: K873986
- Applicant / Sponsor: Schiff & Co.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1988-02-02
Classification & Regulation
This clearance is catalogued under FDA product code DHA and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.