Clearance Summary
CARDIAC STATUS CONTROLS/TROPONIN I received FDA 510(k) clearance under submission number K972687, sponsored by Spectral Diagnostics, 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 1997-07-28.
- Submission: K972687
- Applicant / Sponsor: Spectral Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1997-07-28
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.