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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device abnormal hemoglobin quantitation
Product CodeGKA
Regulation Number 864.7415
Device Class 2


Premarket Reviews
ManufacturerDecision
HELENA LABORATORIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1
SEBIA
  SUBSTANTIALLY EQUIVALENT 1
TRINITY BIOTECH (PRIMUS CORPORATION, DBA TRINITY BIOTECH)
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories, Inc. II May-28-2022
2 Primus Corporation II Oct-31-2020
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