510(k) K051958
K051958 is an FDA 510(k) premarket notification submitted by Mp Biomedicals, LLC for the device "MP RAPIDOXY TEST STRIP, MODEL 07RD-7073". The FDA issued a decision of Substantially Equivalent on July 21, 2006. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Mp Biomedicals, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2006
- Date Received
- July 19, 2005
- 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