DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270— 510(k) K090330
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K090330 for DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270, Substantially Equivalent on 2009-05-22. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- 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
- Newark, DE, US
Recent devices under product code JFY
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K090330
K-number listed on FDA's recall record- Z-2285-2020 — Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
- Z-1233-2020 — Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
- Z-1664-2016 — Dimension Vista Assays: Enzymatic Creatine (ECRE)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090330.
Data sourced from openFDA. This site is unofficial and independent of the FDA.