DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE— 510(k) K112142

Clearance details

Applicant

Siemens Healthcare Diagnostics

Product code

Code NDW

Device class

Class 2

Regulation

21 CFR 862.3560

Advisory panel

Clinical Toxicology

Date received

2011-07-26

Decision date

2011-11-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Newark, DE, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112142.