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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device controls for blood-gases, (assayed and unassayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJS
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
EUROTROL B.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Human Factors Issue 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Radiometer America Inc II Sep-29-2017
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