Clearance Summary
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH received FDA 510(k) clearance under submission number K905861, 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 1991-02-06.
- Submission: K905861
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1445
- Decision date: 1991-02-06
Classification & Regulation
This clearance is catalogued under FDA product code CFE and 21 CFR 862.1445, within the Clinical Chemistry review panel as a Class II device.