Cleared Traditional

MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM

K122553 · ACON Laboratories, Inc. · Hematology
Aug 2013
Decision
349d
Days
Class 2
Risk

About This 510(k) Submission

K122553 is an FDA 510(k) clearance for the MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on August 5, 2013, 349 days after receiving the submission on August 21, 2012. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K122553 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2012
Decision Date August 05, 2013
Days to Decision 349 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKR — System, Hemoglobin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5620

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