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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, rheumatoid factor
Product CodeDHR
Regulation Number 866.5775
Device Class 2


Premarket Reviews
ManufacturerDecision
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KAMIYA BIOMEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Suction Problem 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Hycor Biomedical Inc II Aug-06-2019
2 Hycor Biomedical Inc II Jul-30-2019
3 Phadia Ab II Jul-01-2019
4 Randox Laboratories Ltd. II Nov-04-2019
5 The Binding Site Group, Ltd. II May-22-2020
6 The Binding Site Group, Ltd. II Mar-13-2020
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