Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)— 510(k) K222439
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K222439 for Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc), Substantially Equivalent on 2023-08-08. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code LEH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3950
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code LEH
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More clearances from Siemens Healthcare Diagnostics, Inc.
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