EIA SMDP IMMUNOASSAY— 510(k) K132631

Clearance details

Applicant

Phadia US, Inc.

Product code

Code LKP

Device class

Class 2

Regulation

21 CFR 866.5100

Advisory panel

Immunology

Date received

2013-08-22

Decision date

2014-08-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Portage, MI, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132631.