DIMENSION HAIC ASSAY, MODEL DF105— 510(k) K011852

Clearance details

Applicant

Dade Behring, Inc.

Product code

Code LCP

Device class

Class 2

Regulation

21 CFR 864.7470

Advisory panel

Hematology

Date received

2001-06-12

Decision date

2001-11-15

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 K011852.