Clearance Summary
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K965213, sponsored by Dade Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1997-02-10.
- Submission: K965213
- Applicant / Sponsor: Dade Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5680
- Decision date: 1997-02-10
Classification & Regulation
This clearance is catalogued under FDA product code DDR and 21 CFR 866.5680, within the Immunology review panel as a Class II device.