• 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 nad reduction/nadh oxidation, cpk or isoenzymes
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product CodeCGS
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
SEKISUI DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unable to Obtain Readings 1358
Low Test Results 187
Adverse Event Without Identified Device or Use Problem 3
High Test Results 1
Device Issue 1
Total Device Problems 1550

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Mar-30-2019
2 Medtest Holdings, Inc. III Jun-29-2017
3 Siemens Healthcare Diagnostics, Inc. II May-04-2018

-
-