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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 NameIMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
PMA NumberP010051
Supplement NumberS001
Date Received11/20/2002
Decision Date03/13/2003
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the immulite, immulite 1000 anti-hbc igm and immulite 2000 anti-hbc igm on the immulite 1000 automated analyzer.
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