PMA - Premarket Approval

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New Search Back to Search Results 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 Name CIBA CORNING ACS AFP IMMUNOASSAY Classification Name kit, test, alpha-fetoprotein for neural tube defects Applicant CHIRON DIAGNOSTICS CORP. PMA Number P930036 Date Received 10/18/1993 Decision Date 09/29/1995 Product Code LOK [ Registered Establishments with LOK ] Docket Number 95M-0195 Notice Date 07/03/1996 Advisory Committee Immunology Expedited Review Granted? No Approval Order Statement  Approval for the ciba corning acs afp immunoassay. Supplements: S001 S002 S003