Clearance Summary
MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE received FDA 510(k) clearance under submission number K951835, sponsored by Life Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1995-08-11.
- Submission: K951835
- Applicant / Sponsor: Life Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 1995-08-11
Classification & Regulation
This clearance is catalogued under FDA product code MFD and 21 CFR 884.5250, within the Obstetrics/Gynecology review panel as a Class II device.