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FDA 510(k)

AVIE TOTAL HB TEST SYSTEM

K-Number: K121752 · 2013-01-07

ApplicantMec Dynamics Corp
Decision Date2013-01-07
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AVIE TOTAL HB TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mec Dynamics Corp. It received FDA 510(k) clearance on 2013-01-07 under 510(k) number K121752. 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 AVIE TOTAL HB TEST SYSTEM?

AVIE TOTAL HB TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-07. The listed applicant is Mec Dynamics Corp. The 510(k) number is K121752.

When did AVIE TOTAL HB TEST SYSTEM receive FDA 510(k) clearance?

AVIE TOTAL HB TEST SYSTEM received FDA 510(k) clearance on 2013-01-07, under 510(k) number K121752.

Who is the listed applicant for AVIE TOTAL HB TEST SYSTEM?

The FDA 510(k) record lists Mec Dynamics Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVIE TOTAL HB TEST SYSTEM?

The FDA product code for AVIE TOTAL HB TEST SYSTEM is GKR.

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Other records listing Mec Dynamics Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093548AVIE A1C TEST SYSTEMK091400MODIFICATION TO AVIE A1C TEST SYSTEMK081269AVIE A1C TEST SYSTEM

Related Devices (Code: GKR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201217HemoCue Hb 301 SystemHemocue ABK200909Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbHK181751HemoCue Hb 801 SystemHemocue ABK182298hemochroma PLUS SystemImmunostics Inc.,K172173DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbHK163465hemochroma PLUS SystemImmunostics Inc.,

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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