Clearance Summary
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K950570, sponsored by Baxter 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 1995-04-11.
- Submission: K950570
- Applicant / Sponsor: Baxter Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1620
- Decision date: 1995-04-11
Classification & Regulation
This clearance is catalogued under FDA product code JLS and 21 CFR 862.1620, within the Clinical Chemistry review panel as a Class I device.