FDA 510(k) Premarket Notification K101852: CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT

Submission Details & Decision

Normalized public record details for 510(k) notification K101852.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K101852

Applicant / Sponsor

Iris International Inc., A Division of Iris Iris I

Device Name

CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT

Product Code

KQO

Decision Date

2011-03-23

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2010-07-01

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