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FDA 510(k)

MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM

K-Number: K122553 · 2013-08-05

ApplicantACON Laboratories, Inc.
Decision Date2013-08-05
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2013-08-05 under 510(k) number K122553. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM?

MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-05. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K122553.

When did MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM receive FDA 510(k) clearance?

MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM received FDA 510(k) clearance on 2013-08-05, under 510(k) number K122553.

Who is the listed applicant for MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM?

The FDA product code for MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM is GKR.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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