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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 ANTI-HBS REAGENT PACK & CALIBRATORS
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 NumberP000014
Supplement NumberS003
Date Received03/22/2001
Decision Date04/19/2001
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE TYPE OF DISPENSER USED TO DISPENSE THE COATING SOLUTION AND WASH BUFFERS DURING THE MANUFACTURING OF THE COATED MICROWELLS, A COMPONENT OF THE PRODUCT.
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