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 photometric method, ammonia
Product CodeJID
Regulation Number 862.1065
Device Class 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 26 26
2021 19 19
2022 12 12
2023 26 26
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 67 67
Low Test Results 15 15
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Adverse Event Without Identified Device or Use Problem 7 7
High Readings 4 4
Low Readings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 6 6

-
-