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510(k) K121752

AVIE TOTAL HB TEST SYSTEM by Mec Dynamics Corp — Product Code GKR

K121752 is an FDA 510(k) premarket notification submitted by Mec Dynamics Corp for the device "AVIE TOTAL HB TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on January 7, 2013. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Mec Dynamics Corp has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2013
Date Received
June 14, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemoglobin, Automated
Device Class
Class II
Regulation Number
864.5620
Review Panel
HE
Submission Type

Other clearances by Mec Dynamics Corp

  • K093548 — AVIE A1C TEST SYSTEM (July 20, 2011)
  • K091400 — MODIFICATION TO AVIE A1C TEST SYSTEM (June 11, 2009)
  • K081269 — AVIE A1C TEST SYSTEM (March 20, 2009)

Other clearances for product code GKR

  • K201217 — HemoCue Hb 301 System (August 4, 2020)
  • K200909 — Hemo Control (optional Add Pack Hemo Control DM) (June 12, 2020)
  • K181751 — HemoCue Hb 801 System (February 1, 2019)
  • K182298 — hemochroma PLUS System (November 16, 2018)
  • K172173 — DiaSpect Tm, DiaSpect Tm Cuvettes (April 6, 2018)
  • K163465 — hemochroma PLUS System (September 8, 2017)
  • K122553 — MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM (August 5, 2013)
  • K110393 — EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOG (March 4, 2011)
  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (June 10, 2009)
  • K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (July 18, 2008)

FDA data resources