Clearance Summary
PREP I AUTOMATED SAMPLE PROCESSOR received FDA 510(k) clearance under submission number K780933, sponsored by E.I. Dupont DE Nemours & Co., 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 1978-07-27.
- Submission: K780933
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2260
- Decision date: 1978-07-27
Classification & Regulation
This clearance is catalogued under FDA product code LDM and 21 CFR 862.2260, within the Clinical Chemistry review panel as a Class I device.