Clearance Summary
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. received FDA 510(k) clearance under submission number K843434, sponsored by Iso-Data, 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 1984-10-05.
- Submission: K843434
- Applicant / Sponsor: Iso-Data, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1984-10-05
Classification & Regulation
This clearance is catalogued under FDA product code JQC and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.