Clearance Summary
MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H received FDA 510(k) clearance under submission number K050576, sponsored by Good Biotech Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2005-04-21.
- Submission: K050576
- Applicant / Sponsor: Good Biotech Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5040
- Decision date: 2005-04-21
Classification & Regulation
This clearance is catalogued under FDA product code DDZ and 21 CFR 866.5040, within the Immunology review panel as a Class II device.