N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2— 510(k) K171742
Substantially EquivalentSiemens Healthcare Diagnostics Products GmbH
FDA 510(k) clearance K171742 for N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2, Substantially Equivalent on 2017-11-17. 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
view allData sourced from openFDA. This site is unofficial and independent of the FDA.