Clearance Summary
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U received FDA 510(k) clearance under submission number K100682, sponsored by Wallac OY. 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 2010-07-23.
- Submission: K100682
- Applicant / Sponsor: Wallac OY
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1395
- Decision date: 2010-07-23
Classification & Regulation
This clearance is catalogued under FDA product code JLX and 21 CFR 862.1395, within the Clinical Chemistry review panel as a Class I device.