Clearance Summary
ACCU-PAP T ZONE SAMPLER received FDA 510(k) clearance under submission number K801238, sponsored by Robert Hasselbrack, M.D.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1980-08-12.
- Submission: K801238
- Applicant / Sponsor: Robert Hasselbrack, M.D.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1050
- Decision date: 1980-08-12
Classification & Regulation
This clearance is catalogued under FDA product code HFC and 21 CFR 884.1050, within the Obstetrics/Gynecology review panel as a Class II device.