510(k) K082898
K082898 is an FDA 510(k) premarket notification submitted by Amedica Biotech, Inc. for the device "AMEDICA DRUG SCREEN TEST CUP". The FDA issued a decision of Substantially Equivalent on December 19, 2008. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650. Amedica Biotech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2008
- Date Received
- September 30, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Opiates, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.3650
- Review Panel
- TX
- Submission Type