Clearance Summary
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance under submission number K895380, 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 1989-10-17.
- Submission: K895380
- Applicant / Sponsor: Serono-Baker Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1625
- Decision date: 1989-10-17
Classification & Regulation
This clearance is catalogued under FDA product code CFT and 21 CFR 862.1625, within the Clinical Chemistry review panel as a Class I device.