Clearance Summary
BIOTEST HEMOGLOBIN MEASURING SYSTEM received FDA 510(k) clearance under submission number K020710, sponsored by Biotest Medizintechnik GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2002-08-14.
- Submission: K020710
- Applicant / Sponsor: Biotest Medizintechnik GmbH
- Clearance pathway: Abbreviated
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5620
- Decision date: 2002-08-14
Classification & Regulation
This clearance is catalogued under FDA product code GKR and 21 CFR 864.5620, within the Hematology review panel as a Class II device.