510(k) K222439
K222439 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)". The FDA issued a decision of Substantially Equivalent on August 8, 2023. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2023
- Date Received
- August 12, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Vancomycin
- Device Class
- Class II
- Regulation Number
- 862.3950
- Review Panel
- TX
- Submission Type