RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM— 510(k) K102673

Clearance details

Applicant

Phadia US, Inc.

Product code

Product code DHR

Device class

Class 2

Regulation

21 CFR 866.5775

Advisory panel

Immunology

Date received

2010-09-16

Decision date

2011-09-30

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 K102673.