Clearance Summary
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL received FDA 510(k) clearance under submission number K970100, sponsored by Simplicity 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 1997-03-10.
- Submission: K970100
- Applicant / Sponsor: Simplicity Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1997-03-10
Classification & Regulation
This clearance is catalogued under FDA product code MJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.