AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL— 510(k) K121456

Clearance details

Applicant

Arkray, Inc.

Product code

Code KQO

Device class

Class 1

Regulation

21 CFR 862.2900

Advisory panel

Clinical Chemistry

Date received

2012-05-16

Decision date

2013-02-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Edina, 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 K121456.