Clearance Summary
SOURCERER received FDA 510(k) clearance under submission number K884091, sponsored by John Caunt Scientific , Ltd.. 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: K884091
- Applicant / Sponsor: John Caunt Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2320
- Decision date: 1989-02-02
Classification & Regulation
This clearance is catalogued under FDA product code JJJ and 21 CFR 862.2320, within the Clinical Chemistry review panel as a Class I device.