Clearance Summary
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM received FDA 510(k) clearance under submission number K132076, sponsored by Dsrv, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2014-01-10.
- Submission: K132076
- Applicant / Sponsor: Dsrv, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8950
- Decision date: 2014-01-10
Classification & Regulation
This clearance is catalogued under FDA product code GIR and 21 CFR 864.8950, within the Hematology review panel as a Class I device.