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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay (two-site solid phase), ferritin
Product CodeJMG
Regulation Number 866.5340
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2016 1 1
2017 1 1
2018 3 3
2019 1 1
2020 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Apr-17-2017
2 Siemens Healthcare Diagnostics, Inc. II Aug-08-2019
3 Siemens Healthcare Diagnostics, Inc. II Aug-15-2014
4 Siemens Healthcare Diagnostics, Inc. II Dec-24-2013
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