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FDA 510(k) Application Details - K984079
Device Classification Name
Radioimmunoassay, Human Chorionic Gonadotropin
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510(K) Number
K984079
Device Name
Radioimmunoassay, Human Chorionic Gonadotropin
Applicant
ALFA SCIENTIFIC DESIGNS, INC.
11494 SORRENTO VALLEY RD.,
SUITE F/M
SAN DIEGO, CA 92121 US
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Contact
NAISHU WANG
Other 510(k) Applications for this Contact
Regulation Number
862.1155
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Classification Product Code
JHI
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More FDA Info for this Product Code
Date Received
11/16/1998
Decision Date
02/16/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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