Clearance Summary
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL received FDA 510(k) clearance under submission number K902220, sponsored by Boehringer Mannheim Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1990-09-05.
- Submission: K902220
- Applicant / Sponsor: Boehringer Mannheim Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5700
- Decision date: 1990-09-05
Classification & Regulation
This clearance is catalogued under FDA product code DGR and 21 CFR 866.5700, within the Immunology review panel as a Class I device.