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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.
 
Trade NameARCHITECT CORE-M
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES
PMA NumberP060035
Supplement NumberS013
Date Received11/23/2011
Decision Date12/21/2011
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the quality control testing used on an incoming raw material and a finished accessory used in the device.
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