Clearance Summary
PIPETTES, PLASTIC DISPOSABLE received FDA 510(k) clearance under submission number K781891, sponsored by Hillwood Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1978-11-15.
- Submission: K781891
- Applicant / Sponsor: Hillwood Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.6160
- Decision date: 1978-11-15
Classification & Regulation
This clearance is catalogued under FDA product code GJG and 21 CFR 864.6160, within the Hematology review panel as a Class I device.