Clearance Summary
SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT received FDA 510(k) clearance under submission number K874544, sponsored by Molecular Biosystems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1988-08-12.
- Submission: K874544
- Applicant / Sponsor: Molecular Biosystems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.7675
- Decision date: 1988-08-12
Classification & Regulation
This clearance is catalogued under FDA product code LGO and 21 CFR 864.7675, within the Hematology review panel as a Class I device.