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510(k) K163465

hemochroma PLUS System by Immunostics Inc., — Product Code GKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2017
Date Received
December 12, 2016
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 Immunostics Inc.,

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  • K163225 — AFIAS iFOB with AFIAS-50 (August 8, 2017)
  • K171484 — hema-screen SPECIFIC Gold (June 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K102664 — HEMA SCREEN ER (January 28, 2011)
  • K060463 — HEMA SCREEN SPECIFIC IFOBT (June 6, 2006)
  • K041728 — HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE (August 11, 2004)
  • K031490 — RUBELLACOL (July 16, 2003)
  • K992759 — COLON ALERT TEST (December 6, 1999)

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)
  • 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)
  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (June 10, 2009)
  • K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (July 18, 2008)