DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL— 510(k) K082503

Clearance details

Applicant

Siemens Healthcare Diagnostics

Product code

Code DFH

Device class

Class 2

Regulation

21 CFR 866.5550

Advisory panel

Immunology

Date received

2008-08-29

Decision date

2008-12-19

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 K082503.