Clearance Summary
CAPILLARY BLOOD COLLECTION TUBE received FDA 510(k) clearance under submission number K843608, sponsored by Medical Technomics, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1984-11-30.
- Submission: K843608
- Applicant / Sponsor: Medical Technomics, Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.6150
- Decision date: 1984-11-30
Classification & Regulation
This clearance is catalogued under FDA product code GIO and 21 CFR 864.6150, within the Hematology review panel as a Class I device.