Clearance Summary
DPM CALCULATOR received FDA 510(k) clearance under submission number K810631, 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 1981-03-27.
- Submission: K810631
- Applicant / Sponsor: Iso-Data, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2100
- Decision date: 1981-03-27
Classification & Regulation
This clearance is catalogued under FDA product code JQP and 21 CFR 862.2100, within the Clinical Chemistry review panel as a Class I device.