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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
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HELENA LABORATORIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1
SEBIA
  SUBSTANTIALLY EQUIVALENT 6
TRINITY BIOTECH (PRIMUS CORPORATION, DBA TRINITY BIOTECH)
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories Inc III Apr-14-2011
2 Bio-Rad Laboratories Inc II Mar-29-2011
3 Bio-Rad Laboratories, Inc. II May-28-2022
4 Clark Laboratories, Inc. (dba,Trinity Biotech USA) II Dec-18-2018
5 Primus Corporation II Oct-31-2020
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