Clearance Summary
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K972782, sponsored by Dade Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1997-08-15.
- Submission: K972782
- Applicant / Sponsor: Dade Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1997-08-15
Classification & Regulation
This clearance is catalogued under FDA product code JHX and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.