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TPLC
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Device
hexokinase, glucose
Product Code
CFR
Regulation Number
862.1345
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
AMS
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
DIATRON US, INC.
SUBSTANTIALLY EQUIVALENT
1
ELITECHGROUP
SUBSTANTIALLY EQUIVALENT
1
HITACHI CHEMICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
HORIBA ABX SAS
SUBSTANTIALLY EQUIVALENT
1
MEDICA CORP.
SUBSTANTIALLY EQUIVALENT
1
POLYMEDCO, INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
TOKYO BOEKI MEDISYS INC.
SUBSTANTIALLY EQUIVALENT
1
1. K103531
PRESTIGE 24I; BIOLIS 24I; MGC 240
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
3
3
2016
1
1
2017
13
13
2018
8
8
2019
10
10
2020
4
4
2021
5
5
2022
3
3
2023
29
29
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
41
41
High Test Results
22
22
Non Reproducible Results
20
20
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Incorrect Or Inadequate Test Results
4
4
Contamination
1
1
False Reading From Device Non-Compliance
1
1
Incorrect Measurement
1
1
Low Readings
1
1
Calibration Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
44
44
No Known Impact Or Consequence To Patient
20
20
No Consequences Or Impact To Patient
19
19
No Information
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Horiba Instruments Inc
II
Feb-02-2016
2
JAS Diagnostics Inc.
II
Dec-18-2014
3
Mindray DS USA, Inc. d.b.a. Mindray North America
II
Mar-22-2013
4
Pointe Scientific, Inc.
I
Nov-04-2009
5
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
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