Clearance Summary
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER received FDA 510(k) clearance under submission number K092911, sponsored by Diazyme Laboratories. 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 2010-04-26.
- Submission: K092911
- Applicant / Sponsor: Diazyme Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2010-04-26
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.