Dimension Vista MMB Assay— 510(k) K143720

Clearance details

Applicant

Siemens Healthcare Diagnostics

Product code

Code JHY

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

2014-12-29

Decision date

2015-09-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Newark, DE, US

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• Z-0330-2022 — Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20211015
• Z-0331-2022 — Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20211015
• Z-1015-2019 — Dimension Vista 1500, Analyzer, chemistry Model no. 10444801Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20181212
• Z-0617-2019 — Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20181016
• Z-1672-2018 — Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridgeClass II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180102

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143720.