Clearance Summary
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 received FDA 510(k) clearance under submission number K020138, sponsored by Gds Technology. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2002-02-11.
- Submission: K020138
- Applicant / Sponsor: Gds Technology
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7500
- Decision date: 2002-02-11
Classification & Regulation
This clearance is catalogued under FDA product code KHG and 21 CFR 864.7500, within the Hematology review panel as a Class II device.