510(k) DEN990008
DEN990008 is an FDA 510(k) premarket notification submitted by Wallac, Inc. for the device "WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000". The FDA issued a decision of De Novo Granted on February 15, 2000. The device falls under product code NAK (System, Test, Biotinidase), a Class II device regulated under 21 CFR 862.1118. Wallac, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 15, 2000
- Date Received
- December 20, 1999
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Biotinidase
- Device Class
- Class II
- Regulation Number
- 862.1118
- Review Panel
- CH
- Submission Type