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FDA 510(k) Application Details - K032987
Device Classification Name
Radioimmunoassay, Human Chorionic Gonadotropin
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510(K) Number
K032987
Device Name
Radioimmunoassay, Human Chorionic Gonadotropin
Applicant
UNOTECH DIAGNOSTICS, INC.
2235 POLVOROSA AVE., SUITE 220
SAN LEANDRO, CA 94577 US
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Contact
KEN WU
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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
09/24/2003
Decision Date
11/17/2003
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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