510(k) K151441
K151441 is an FDA 510(k) premarket notification submitted by W.H.P.M., Inc. for the device "First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test". The FDA issued a decision of Substantially Equivalent on June 29, 2015. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. W.H.P.M., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2015
- Date Received
- May 29, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Methadone
- Device Class
- Class II
- Regulation Number
- 862.3620
- Review Panel
- TX
- Submission Type