Clearance Summary
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 received FDA 510(k) clearance under submission number K030573, sponsored by Bd Vacutainer Systems Preanalyical Solutions. 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 2003-05-08.
- Submission: K030573
- Applicant / Sponsor: Bd Vacutainer Systems Preanalyical Solutions
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2003-05-08
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.