IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE— 510(k) K093861

Clearance details

Applicant

Iris International, Inc.

Product code

Code LKM

Device class

Class 2

Regulation

21 CFR 864.5200

Advisory panel

Hematology

Date received

2009-12-16

Decision date

2010-02-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Chatsworth, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093861.