Clearance Summary
NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D received FDA 510(k) clearance under submission number K101392, sponsored by Astoria-Pacific, 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 2011-02-04.
- Submission: K101392
- Applicant / Sponsor: Astoria-Pacific, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1315
- Decision date: 2011-02-04
Classification & Regulation
This clearance is catalogued under FDA product code KQP and 21 CFR 862.1315, within the Clinical Chemistry review panel as a Class II device.