• 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 colorimeter, photometer, spectrophotometer for clinical use
Regulation Description Colorimeter, photometer, or spectrophotometer for clinical use.
Product CodeJJQ
Regulation Number 862.2300
Device Class 1

Device Problems
Adverse Event Without Identified Device or Use Problem 9
Low Readings 4
Calibration Problem 4
Use of Device Problem 3
Mechanical Problem 3
Smoking 2
Device Operates Differently Than Expected 2
Insufficient Information 2
Low Test Results 2
Incorrect Software Programming Calculations 1
High Test Results 1
Total Device Problems 33

Recalls
Manufacturer Recall Class Date Posted
1 QIAGEN Gaithersburg, Inc. II Jun-26-2015
2 Tecan US, Inc. II Aug-25-2016

-
-