Clearance Summary
PROGESTERONE TEST SET 125I 17-OH received FDA 510(k) clearance under submission number K834246, sponsored by Wien Laboratories, 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 1984-02-04.
- Submission: K834246
- Applicant / Sponsor: Wien Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1395
- Decision date: 1984-02-04
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.