SENTINEL PLASMAPROTEINS CAL 3X— 510(k) K051457

Clearance details

Applicant

Sentinel Ch. Srl

Product code

Code JIX

Device class

Class 2

Regulation

21 CFR 862.1150

Advisory panel

Clinical Chemistry

Date received

2005-06-02

Decision date

2005-07-25

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Milano, IT

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051457.