ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS— 510(k) K072658
Substantially EquivalentSiemens Medical Solutions Diagnostics
FDA 510(k) clearance K072658 for ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS, Substantially Equivalent on 2008-04-01. Applicant: Siemens Medical Solutions Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions Diagnostics
- Product code
- Code DCN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code DCN
view allMore clearances from Siemens Medical Solutions Diagnostics
view all- K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
- K091984 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
- K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
- K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
- K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
Data sourced from openFDA. This site is unofficial and independent of the FDA.