510(k) K041746
K041746 is an FDA 510(k) premarket notification submitted by Lifepoint,Inc for the device "IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)". The FDA issued a decision of Substantially Equivalent on November 23, 2004. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Lifepoint,Inc has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2004
- Date Received
- June 29, 2004
- 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