Clearance Summary
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 received FDA 510(k) clearance under submission number K980770, sponsored by Diagnostic Chemicals , Ltd.. 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 1998-04-21.
- Submission: K980770
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1998-04-21
Classification & Regulation
This clearance is catalogued under FDA product code LBR and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.