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 cresolphthalein complexone, calcium
Product CodeCIC
Regulation Number 862.1145
Device Class 2


Premarket Reviews
ManufacturerDecision
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 30 30
2017 6 6
2018 42 42
2021 1 1
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 81 81
High Test Results 6 6
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 77 77
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Horiba Instruments, Inc dba Horiba Medical III Sep-26-2013
2 MEDLINE INDUSTRIES, LP - Northfield II May-26-2022
3 Pointe Scientific, Inc. II Mar-10-2010
4 Roche Diagnostics Operations, Inc. II Mar-25-2011
5 Siemens Healthcare Diagnostics, Inc. II Apr-27-2018
6 Siemens Healthcare Diagnostics, Inc. II Oct-04-2016
-
-