Clearance Summary
SR1 DHEA-S ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K942051, sponsored by Serono Diagnostics, 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 1994-07-13.
- Submission: K942051
- Applicant / Sponsor: Serono Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1245
- Decision date: 1994-07-13
Classification & Regulation
This clearance is catalogued under FDA product code JKC and 21 CFR 862.1245, within the Clinical Chemistry review panel as a Class I device.