Clearance Summary
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT received FDA 510(k) clearance under submission number K860335, sponsored by Diagnostic Products Corp.. 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 1986-04-24.
- Submission: K860335
- Applicant / Sponsor: Diagnostic Products Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1395
- Decision date: 1986-04-24
Classification & Regulation
This clearance is catalogued under FDA product code JLX and 21 CFR 862.1395, within the Clinical Chemistry review panel as a Class I device.