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
panels, test, susceptibility, antimicrobial
Product Code
LTT
Regulation Number
866.1640
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER INC.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
2
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
6
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
3
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HELATHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
9
9
2015
10
10
2016
1
1
2017
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect Or Inadequate Test Results
12
12
Nonstandard Device
8
8
Adverse Event Without Identified Device or Use Problem
4
4
Device Operates Differently Than Expected
4
4
False Negative Result
1
1
Product Quality Problem
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
11
11
No Information
6
6
No Patient Involvement
4
4
Not Applicable
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Aug-02-2018
2
Beckman Coulter Inc.
II
Dec-30-2015
3
Beckman Coulter Inc.
II
Oct-07-2015
4
Siemens Healthcare Diagnostics, Inc.
II
Jun-08-2013
5
Siemens Healthcare Diagnostics, Inc.
II
May-08-2013
-
-