Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device hexokinase, glucose
Regulation Description Glucose test system.
Product CodeCFR
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND
  SUBSTANTIALLY EQUIVALENT 1
  1.  K252357  Glucose2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 5 5
2022 3 3
2023 29 30
2024 15 15
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 30 31
Non Reproducible Results 28 29
High Test Results 21 21
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Incorrect Measurement 3 3
Output Problem 1 1
Material Integrity Problem 1 1
Contamination 1 1
Unable to Obtain Readings 1 1
Low Readings 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72 73
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 2 2

-
-