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FDA 510(k) Application Details - K974615
Device Classification Name
Radioimmunoassay, Human Chorionic Gonadotropin
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510(K) Number
K974615
Device Name
Radioimmunoassay, Human Chorionic Gonadotropin
Applicant
PHAMATECH
9265 ACTIVITY RD., #112-113
SAN DIEGO, CA 92126 US
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Contact
CARL A MONGIOVI
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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
12/11/1997
Decision Date
01/26/1998
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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