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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device software, blood bank, stand alone products
Regulation Description Automated blood grouping and antibody test system.
Product CodeMMH
Regulation Number 864.9175
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 3
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 7
Data Innovations Inc.
  SUBSTANTIALLY EQUIVALENT 4
EPIC
  SUBSTANTIALLY EQUIVALENT 1
FIFTH DIMENSION INFORMATION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
GLOBAL MED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 8
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 9
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
INFORMATION DATA MANAGEMENT, INC.
  SUBSTANTIALLY EQUIVALENT 12
KENDALL
  SUBSTANTIALLY EQUIVALENT 4
  1.  BK030049  Blood Establishment Computer Software and Accessor ...
  2.  BK060058  Blood Establishment Computer Software and Accessor ...
  3.  BK080044  Blood Establishment Computer Software and Accessor ...
  4.  BK120030  Blood Establishment Computer Software and Accessor ...
MCKESSON
  SUBSTANTIALLY EQUIVALENT 1
MISYS HOSPITAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 3
RED CROSS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SCC
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Computer software issue 3
Incorrect display 1
Date-related software issue 1
Pipette, failure to aspirate 1
No Information 1
Alarm, failure of warning 1
Total Device Problems 8

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