Clearance Summary
SERIM LEUKOCYTE ESTERASE TEST STRIPS received FDA 510(k) clearance under submission number K000578, sponsored by Serim Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2000-05-05.
- Submission: K000578
- Applicant / Sponsor: Serim Research Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.7675
- Decision date: 2000-05-05
Classification & Regulation
This clearance is catalogued under FDA product code LJX and 21 CFR 864.7675, within the Hematology review panel as a Class I device.