Emit® II Plus Buprenorphine Assay— 510(k) K221605
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K221605 for Emit® II Plus Buprenorphine Assay, Substantially Equivalent on 2023-07-25. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code DJG
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