Clearance Summary
FLUID SAMPLING PACK received FDA 510(k) clearance under submission number K874436, sponsored by U.S. Mfg. & Management, 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 1988-01-05.
- Submission: K874436
- Applicant / Sponsor: U.S. Mfg. & Management, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.9050
- Decision date: 1988-01-05
Classification & Regulation
This clearance is catalogued under FDA product code KSS and 21 CFR 864.9050, within the Hematology review panel as a Class I device.