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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device nadh oxidation/nad reduction, alt/sgpt
Product CodeCKA
Regulation Number 862.1030
Device Class 1


Premarket Reviews
ManufacturerDecision
ALFA WASSERMANN
  SUBSTANTIALLY EQUIVALENT 1
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 1 1
2020 3 3
2021 2 2
2022 2 2
2023 5 5
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 4 4
Low Test Results 3 3
Unable to Obtain Readings 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Non Reproducible Results 2 2
Unexpected Therapeutic Results 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abaxis, Incorporated II Feb-09-2011
2 Abbott Laboratories II Aug-02-2021
3 Alfa Wassermann, Inc. II Apr-30-2014
4 Siemens Healthcare Diagnostics, Inc. II May-04-2018
5 Sterling Diagnostics, Inc. III Dec-29-2016
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