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 phosphomolybdate (colorimetric), inorganic phosphorus
Product CodeCEO
Regulation Number 862.1580
Device Class 1


Premarket Reviews
ManufacturerDecision
SEPPIM S.A.S.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 3 3
2017 4 4
2018 2 2
2019 2 2
2020 2 2
2021 3 3
2022 2 2
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 12 12
High Test Results 10 10
Non Reproducible Results 3 3
Incorrect Measurement 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Or Inadequate Test Results 1 1
No Device Output 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 4 4
Heart Failure 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Sep-10-2010
2 Abbott Laboratories, Inc II Oct-17-2013
3 Alfa Wassermann, Inc. II Jan-28-2013
4 Ortho-Clinical Diagnostics II Nov-15-2013
5 Siemens Healthcare Diagnostics, Inc. II Apr-02-2013
-
-