510(k) K132076
K132076 is an FDA 510(k) premarket notification submitted by Dsrv, Inc. for the device "REAGENT, RUSSEL VIPER VENOM - LA CONFIRM". The FDA issued a decision of Substantially Equivalent on Jan 10, 2014. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950. Dsrv, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 10, 2014
- Date Received
- Jul 3, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Reagent, Russel Viper Venom
- Device Class
- Class I
- Regulation Number
- 864.8950
- Review Panel
- HE
- Submission Type
- 510(k)