Clearance Summary
EMIT URINE METHADONE ASSAY #3E319 received FDA 510(k) clearance under submission number K820900, sponsored by Syva Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1982-04-26.
- Submission: K820900
- Applicant / Sponsor: Syva Co.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5200
- Decision date: 1982-04-26
Classification & Regulation
This clearance is catalogued under FDA product code DDE and 21 CFR 866.5200, within the Immunology review panel as a Class I device.