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510(k) K090093

STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM by Stanbio Laboratory — Product Code GKR

K090093 is an FDA 510(k) premarket notification submitted by Stanbio Laboratory for the device "STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 10, 2009. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Stanbio Laboratory has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2009
Date Received
January 14, 2009
Clearance Type
Special
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 Stanbio Laboratory

  • K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (July 18, 2008)
  • K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (June 30, 2005)
  • K050283 — CREATININE LIQUICOLOR (June 30, 2005)
  • K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (March 14, 2005)
  • K041155 — WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY (October 14, 2004)
  • K032936 — DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIB (March 12, 2004)
  • K032932 — DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (March 10, 2004)
  • K032482 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (October 24, 2003)
  • K020378 — QUPID PLUS E.R. (June 21, 2002)
  • K974429 — RAPET CRP (February 18, 1998)

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)
  • K121752 — AVIE TOTAL HB TEST SYSTEM (January 7, 2013)
  • K110393 — EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOG (March 4, 2011)
  • K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (July 18, 2008)

FDA data resources