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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.
 
Device Micro trak II Igm Anti-HBCore EIA
Classification Namesystem, identification, hepatitis b antigen
Generic Nameidentification system for hepatitis b antigen
Applicant
DiaSorin, Inc.
1990 industrial blvd.
Stillwater , MN 55082 
  
PMA NumberBP860031
Supplement NumberS005
Date Received06/27/2001
Decision Date07/24/2001
Decision Approved
Product Code
KSJ[ Registered Establishments with KSJ ]
Advisory Committee Hematology
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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