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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Device Immucor PreciseType™ Human Erythrocyte Antigen Molecular BeadChip Test
Classification Namemolecular erythrocyte typing test
Generic Namemolecular erythrocyte typing test
Applicant
BioArray Solutions, Ltd.
35 technology drive suite 100
Warren , NJ 07059 
  
PMA NumberBP130026
Supplement NumberS004
Date Received06/17/2015
Decision Date06/26/2015
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
PEP[ Registered Establishments with PEP ]
Advisory Committee Hematology
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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