Clearance Summary
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT received FDA 510(k) clearance under submission number K911839, sponsored by Pantex, Div. Bio-Analysis, 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 1991-06-18.
- Submission: K911839
- Applicant / Sponsor: Pantex, Div. Bio-Analysis, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1395
- Decision date: 1991-06-18
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.