Clearance Summary
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE received FDA 510(k) clearance under submission number K141220, sponsored by Thermo Fisher Scientific (Life Technologies Holdin. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2014-05-22.
- Submission: K141220
- Applicant / Sponsor: Thermo Fisher Scientific (Life Technologies Holdin
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.2570
- Decision date: 2014-05-22
Classification & Regulation
This clearance is catalogued under FDA product code NSU and 21 CFR 862.2570, within the Clinical Chemistry review panel as a Class II device.