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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated urinalysis system
Product CodeKQO
Regulation Number 862.2900
Device Class 1


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARJ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARKRAY, INC.
  SUBSTANTIALLY EQUIVALENT 2
DFI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K093555  COBAS U411 TEST SYSTEM
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
YD DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Arkray Factory USA, Inc. II Jun-20-2019
2 Beckman Coulter Inc. II May-09-2020
3 Beckman Coulter Inc. II Jan-29-2020
4 Beckman Coulter Inc. II Jan-23-2020
5 Beckman Coulter Inc. II Jul-03-2019
6 Beckman Coulter Inc. II May-04-2018
7 Beckman Coulter Inc. II Apr-27-2018
8 Beckman Coulter Inc. II Apr-12-2018
9 Beckman Coulter Inc. II Apr-11-2018
10 Beckman Coulter Inc. II Mar-01-2017
11 Beckman Coulter Inc. II Mar-08-2016
12 Beckman Coulter, Inc. II May-17-2023
13 Beckman Coulter, Inc. II Mar-20-2020
14 HemoCue AB II Oct-25-2013
15 Iris Diagnostics II Aug-21-2015
16 Roche Diagnostics Operations, Inc. II Nov-18-2021
17 Siemens Healthcare Diagnostics Inc III May-04-2014
18 Sysmex America, Inc. II Apr-15-2020
19 Teco Diagnostics II Jan-11-2012
20 Teco Diagnostics II Dec-09-2010
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