510(k) K203527
K203527 is an FDA 510(k) premarket notification submitted by Lmmunalysis Corporation for the device "Immunalysis Tapentadol Urine HEIA". The FDA issued a decision of Substantially Equivalent on May 9, 2022. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2022
- Date Received
- Dec 2, 2020
- 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
- 510(k)