Avl Omni Analyzer

FDA 510(k) K954018 · Avl Scientific Corp.

Substantially Equivalent

510(k) numberK954018

Submission

Device name
Avl Omni Analyzer
Applicant
Avl Scientific Corp.
Roswell, GA, US
Received
August 25, 1995
Decision date
October 5, 1995
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
K200909Hemo Control (optional Add Pack Hemo Control DM)GKR · Special Ekf-Diagnostic GmbH06/12/2020SE
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
K121752Avie Total HB Test SystemGKR · Traditional Mec Dynamics Corp01/07/2013SE
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

More from Stanbio Laboratory

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K984299Avl Opti Critical Care AnalyzerJFP · Traditional 12/11/1998SE
K974784Avl Opti Critical Care AnalyzerCEM · Traditional 02/24/1998SE
K974822Avl Opti-Check Ph/ Blood Gas/ Electrolyte/Thb/ SO2 ControlJJY · Traditional 01/22/1998SE
K972733Avl Omni AnalyzerCGA · Traditional 09/09/1997SE
K972673Avl 9181 Electrolyte AnalyzerJFP · Traditional 08/20/1997SE
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Questions and answers

When was Avl Omni Analyzer cleared by the FDA?

Avl Omni Analyzer (K954018) received a 510(k) decision of Substantially Equivalent on October 5, 1995, 41 days after the submission was received.

What is the product code of K954018?

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