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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
assay, glycosylated hemoglobin
Regulation Description
Glycosylated hemoglobin assay.
Product Code
LCP
Regulation Number
864.7470
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
SUBSTANTIALLY EQUIVALENT
1
JANA CARE, INC
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
QURASENSE
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
13
13
2021
7
8
2022
8
8
2023
34
34
2024
46
46
2025
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
62
62
Non Reproducible Results
21
21
Incorrect, Inadequate or Imprecise Result or Readings
17
17
Low Test Results
12
12
Output Problem
5
5
No Apparent Adverse Event
4
4
Use of Device Problem
3
3
Smoking
2
2
High Readings
2
2
Incorrect Measurement
2
2
Leak/Splash
1
1
Chemical Problem
1
1
Fire
1
1
Mechanical Problem
1
1
Device Markings/Labelling Problem
1
1
Insufficient Information
1
1
Fail-Safe Did Not Operate
1
1
Material Integrity Problem
1
1
Patient Data Problem
1
1
Unable to Obtain Readings
1
2
Data Problem
1
1
Low Readings
1
1
Failure to Calibrate
1
1
Appropriate Term/Code Not Available
1
1
False Positive Result
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
99
100
No Known Impact Or Consequence To Patient
7
7
No Consequences Or Impact To Patient
4
4
Exposure to Body Fluids
1
1
No Patient Involvement
1
1
Hyperglycemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Diagnostics Technologies AS
II
Aug-27-2024
2
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
II
Oct-24-2024
3
Siemens Healthcare Diagnostics, Inc.
II
Mar-19-2024
4
Siemens Healthcare Diagnostics, Inc.
II
Apr-14-2022
5
Siemens Healthcare Diagnostics, Inc.
II
Jul-31-2020
6
Siemens Healthcare Diagnostics, Inc.
II
Jun-05-2020
-
-