DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR— 510(k) K061793

Clearance details

Applicant

Dade Behring, Inc.

Product code

Code JIY

Device class

Class 1

Regulation

21 CFR 862.1410

Advisory panel

Clinical Chemistry

Date received

2006-06-26

Decision date

2006-08-07

Decision

Substantially Equivalent

Clearance type

Special

Location

Newark, DE, US

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• Z-0452-2013 — Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20121008

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061793.