Clearance Summary
SALMONELLA IFA* received FDA 510(k) clearance under submission number K885114, sponsored by Investigacion Farmaceutica S.A. DE C.V.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1989-08-15.
- Submission: K885114
- Applicant / Sponsor: Investigacion Farmaceutica S.A. DE C.V.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.6700
- Decision date: 1989-08-15
Classification & Regulation
This clearance is catalogued under FDA product code GHC and 21 CFR 864.6700, within the Hematology review panel as a Class I device.