ADVIA CHEMISTRY ENZYMATIC CREATININE_2— 510(k) K070727
Substantially EquivalentSiemens Medical Solutions Diagnostics
FDA 510(k) clearance K070727 for ADVIA CHEMISTRY ENZYMATIC CREATININE_2, Substantially Equivalent on 2007-08-03. Applicant: Siemens Medical Solutions Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions Diagnostics
- Product code
- Code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code JFY
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- 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
Recalls naming K070727
K-number listed on FDA's recall record- Z-2282-2020 — ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
- Z-2283-2020 — Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
- Z-1230-2020 — ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
- Z-1231-2020 — Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
- Z-1654-2016 — ADVIA CHEMISTRY ENZYMATIC CREATININE_2
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070727.
Data sourced from openFDA. This site is unofficial and independent of the FDA.