Clearance Summary
DISPOSABLE CONTROLLED DROP PASTEUR PIPET received FDA 510(k) clearance under submission number K780237, sponsored by Owens-Illinois, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1978-03-09.
- Submission: K780237
- Applicant / Sponsor: Owens-Illinois, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.6160
- Decision date: 1978-03-09
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.