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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantOrtho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101
PMA NumberP090028
Supplement NumberS004
Date Received10/17/2012
Decision Date11/13/2012
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.
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