Clearance Summary
THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE received FDA 510(k) clearance under submission number K012943, sponsored by Quantech , 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 2002-01-18.
- Submission: K012943
- Applicant / Sponsor: Quantech , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2002-01-18
Classification & Regulation
This clearance is catalogued under FDA product code NAL and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.