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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device colorimetric method, lipoproteins
Product CodeJHM
Regulation Number 862.1475
Device Class 1


Premarket Reviews
ManufacturerDecision
ABAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Oct-14-2022
2 Siemens Healthcare Diagnostics, Inc. II Mar-08-2021
3 Siemens Healthcare Diagnostics, Inc. II May-11-2016
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