Clearance Summary
COAT-A-COUNT NEONATAL TSH IRMA received FDA 510(k) clearance under submission number K943195, sponsored by Diagnostic Products Corp.. 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 1995-03-13.
- Submission: K943195
- Applicant / Sponsor: Diagnostic Products Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1690
- Decision date: 1995-03-13
Classification & Regulation
This clearance is catalogued under FDA product code JLW and 21 CFR 862.1690, within the Clinical Chemistry review panel as a Class II device.