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510(k) K954018

AVL OMNI ANALYZER by Avl Scientific Corp. — Product Code GKR

K954018 is an FDA 510(k) premarket notification submitted by Avl Scientific Corp. for the device "AVL OMNI ANALYZER". The FDA issued a decision of Substantially Equivalent on October 5, 1995. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Avl Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1995
Date Received
August 25, 1995
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 Avl Scientific Corp.

  • K001632 — OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 (June 19, 2000)
  • K000103 — AVL OPTI R ANALYZER (March 20, 2000)
  • K993837 — AVL OPTI CRITICAL CARE ANALYZER (December 16, 1999)
  • K990092 — AVL OMNI MODULAR ANALYZER (January 29, 1999)
  • K984299 — AVL OPTI CRITICAL CARE ANALYZER (December 11, 1998)
  • K974784 — AVL OPTI CRITICAL CARE ANALYZER (February 24, 1998)
  • K974822 — AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL (January 22, 1998)
  • K972733 — AVL OMNI ANALYZER (September 9, 1997)
  • K972673 — AVL 9181 ELECTROLYTE ANALYZER (August 20, 1997)
  • K963964 — AVL COMPACT 3 PH/BLOOD GAS ANALYZER (November 29, 1996)

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

FDA data resources