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FDA 510(k) Application Details - K010593
Device Classification Name
Radioimmunoassay, Human Chorionic Gonadotropin
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510(K) Number
K010593
Device Name
Radioimmunoassay, Human Chorionic Gonadotropin
Applicant
SA SCIENTIFIC, INC.
4919 GOLDEN QUAIL
SAN ANTONIO, TX 78240 US
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Contact
ARBI A SHADFAN
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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
02/28/2001
Decision Date
04/05/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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