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 kit, test, alpha-fetoprotein for neural tube defects
Product CodeLOK
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
8 6 9 4 5 0

MDR Year MDR Reports MDR Events
2021 15 15
2022 10 10
2023 11 11
2024 5 5
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 43 43
Low Test Results 13 13
High Readings 3 3
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
Needle Stick/Puncture 1 1

-
-