510(k) K990580
K990580 is an FDA 510(k) premarket notification submitted by Precision Biologic for the device "CRYOCHECK LA SURE, MODEL SUR25-10". The FDA issued a decision of Substantially Equivalent on Jul 28, 1999. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950. Precision Biologic has 16 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 28, 1999
- Date Received
- Feb 23, 1999
- Clearance Type
- Traditional
- 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)