Clearance Summary
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance under submission number K884794, sponsored by Serono-Baker 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 1989-02-02.
- Submission: K884794
- Applicant / Sponsor: Serono-Baker Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1620
- Decision date: 1989-02-02
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.