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 alkaline picrate, colorimetry, creatinine
Regulation Description Creatinine test system.
Product CodeCGX
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRUVIAN HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 13 13
2022 23 23
2023 19 19
2024 32 32
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 64 64
Low Test Results 34 34
Non Reproducible Results 27 27
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Output Problem 2 2
Incorrect Measurement 2 2
Pressure Problem 1 1
Material Integrity Problem 1 1
High Readings 1 1
Unable to Obtain Readings 1 1
Improper Flow or Infusion 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
Exposure to Body Fluids 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
-
-