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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSTRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY
Classification Namesystem, test, carcinoembryonic antigen
Generic Namecarcinoembryonic antigen test system
Regulation Number866.6010
ApplicantHYBRITECH, INC.
PMA NumberP840019
Supplement NumberS010
Date Received09/05/1991
Decision Date03/17/1994
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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