Clearance Summary
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 received FDA 510(k) clearance under submission number K022643, sponsored by Swemed Lab International AB. 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 2002-11-05.
- Submission: K022643
- Applicant / Sponsor: Swemed Lab International AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6130
- Decision date: 2002-11-05
Classification & Regulation
This clearance is catalogued under FDA product code MQH and 21 CFR 884.6130, within the Obstetrics/Gynecology review panel as a Class II device.