DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M— 510(k) K083463

Clearance details

Applicant

Siemens Healthcare Diagnostics

Product code

Code JZG

Device class

Class 2

Regulation

21 CFR 866.5630

Advisory panel

Immunology

Date received

2008-11-24

Decision date

2009-03-13

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 K083463.