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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, automated blood grouping and antibody
Product CodeKSZ
Regulation Number 864.9175
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 2
BIO-RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 17
DIAGNOSTIC GRIFOLS, S. A.
  SUBSTANTIALLY EQUIVALENT 18
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 19
MICRO TYPING SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 5
OLYMPUS AMERICA INC., DIAGNOSTIC SYSTEMS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRATEC BIOMEDICAL UK LIMITED
  SUBSTANTIALLY EQUIVALENT 2

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