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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY
Generic NameSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Regulation Number866.6010
ApplicantHybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego, CA 92126
PMA NumberP840019
Supplement NumberS010
Date Received09/05/1991
Decision Date03/17/1994
Product Code DHX 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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