Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
counter, urine particle
Product Code
LKM
Regulation Number
864.5200
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARKRAY INC.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
IRIS INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SYSMEX AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
1
1
2016
3
3
2017
1
1
2019
2
2
2020
2
2
2021
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2
2
Improper Device Output
1
1
False Negative Result
1
1
Smoking
1
1
Obstruction of Flow
1
1
Incorrect Or Inadequate Test Results
1
1
High Test Results
1
1
Device Handling Problem
1
1
Device Emits Odor
1
1
No Apparent Adverse Event
1
1
False Positive Result
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
6
6
No Patient Involvement
2
2
No Code Available
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Jan-29-2020
2
Beckman Coulter, Inc.
II
Jan-25-2024
3
Sysmex America, Inc.
II
Feb-10-2014
-
-