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 radioimmunoassay, calcitonin
Product CodeJKR
Regulation Number 862.1140
Device Class 2


Premarket Reviews
ManufacturerDecision
AXIS-SHIELD DIAGNOSTICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2016 3 3
2017 7 7
2018 1 1
2019 5 5
2020 1 1
2021 3 3
2022 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Low Test Results 8 8
High Test Results 5 5
Non Reproducible Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Clinical Signs, Symptoms or Conditions 8 8
No Consequences Or Impact To Patient 5 5
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerica II Dec-16-2014
-
-