Avie Total HB Test System

FDA 510(k) K121752 · Mec Dynamics Corp

Substantially Equivalent

510(k) numberK121752

Submission

Device name
Avie Total HB Test System
Applicant
Mec Dynamics Corp
San Jose, CA, US
Received
June 14, 2012
Decision date
January 7, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GKR – System, Hemoglobin, Automated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5620
Specialty
Hematology

Other 510(k)s with product code GKR

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K201217HemoCue Hb 301 SystemGKR · Traditional Hemocue AB08/04/2020SE
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K181751HemoCue Hb 801 SystemGKR · Traditional Hemocue AB02/01/2019SE
K182298hemochroma PLUS SystemGKR · Traditional Immunostics Inc.,11/16/2018SE
K172173DiaSpect Tm, DiaSpect Tm CuvettesGKR · Traditional Ekf-Diagnostic GmbH04/06/2018SE
K163465hemochroma PLUS SystemGKR · Traditional Immunostics Inc.,09/08/2017SE
K122553Mission Plus HB Hemoglobin Testing SystemGKR · Traditional ACON Laboratories, Inc.08/05/2013SE
K110393Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin…GKR · Special Ekf-Diagnostic GmbH03/04/2011SE
K090093Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemGKR · Special Stanbio Laboratory06/10/2009SE
K081719Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Special Stanbio Laboratory07/18/2008SE

More from Stanbio Laboratory

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K093548Avie A1C Test SystemLCP · Traditional 07/20/2011SE
K091400Modification to Avie A1C Test SystemLCP · Special 06/11/2009SE
K081269Avie A1C Test SystemLCP · Traditional 03/20/2009SE

Questions and answers

When was Avie Total HB Test System cleared by the FDA?

Avie Total HB Test System (K121752) received a 510(k) decision of Substantially Equivalent on January 7, 2013, 207 days after the submission was received.

What is the product code of K121752?

The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.