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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, cortisol
Product CodeCGR
Regulation Number 862.1205
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
IMMUNODIAGNOSTIC SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 2 2
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 2 2
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Sep-30-2019
2 Beckman Coulter Inc. II Jul-08-2011
3 Beckman Coulter Inc. II Sep-29-2010
4 Siemens Healthcare Diagnostics II Oct-23-2014
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