N Latex FLC kappa assay, N Latex FLC lambda assay— 510(k) K182098
Substantially EquivalentSiemens Healthcare Diagnostics Products GmbH
FDA 510(k) clearance K182098 for N Latex FLC kappa assay, N Latex FLC lambda assay, Substantially Equivalent on 2018-11-01. Applicant: Siemens Healthcare Diagnostics Products GmbH. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
- Product code
- Code DFH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marburg, DE
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More clearances from Siemens Healthcare Diagnostics Products GmbH
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