Clearance Summary
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET received FDA 510(k) clearance under submission number K861855, sponsored by Sterling 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 1986-06-16.
- Submission: K861855
- Applicant / Sponsor: Sterling Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1380
- Decision date: 1986-06-16
Classification & Regulation
This clearance is catalogued under FDA product code JKF and 21 CFR 862.1380, within the Clinical Chemistry review panel as a Class I device.