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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP930036
Date Received10/18/1993
Decision Date09/29/1995
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 95M-0195
Notice Date 07/03/1996
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ciba corning acs afp immunoassay.
Supplements: S001 S002 S003 S004 S005 
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