510(k) K991883
K991883 is an FDA 510(k) premarket notification submitted by Advantage Diagnostics Corp. for the device "REDI-TEST OPIATES". The FDA issued a decision of Substantially Equivalent on September 15, 1999. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Advantage Diagnostics Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 1999
- Date Received
- June 2, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Opiates
- Device Class
- Class II
- Regulation Number
- 862.3650
- Review Panel
- TX
- Submission Type