3M ATTEST(TM) AUTO-READER— 510(k) K123546

Clearance details

Applicant

3M Company

Product code

Code FRC

Device class

Class 2

Regulation

21 CFR 880.2800

Advisory panel

General Hospital

Date received

2012-11-19

Decision date

2013-03-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St. Paul, MN, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123546.