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FDA 510(k) Application Details - K960992
Device Classification Name
Radioimmunoassay, Human Chorionic Gonadotropin
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510(K) Number
K960992
Device Name
Radioimmunoassay, Human Chorionic Gonadotropin
Applicant
BIONIKE LABORATORIES, INC.
1206 SESAME DR.
SUNNYVALE, CA 94087 US
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JANIS FREESTONE
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Regulation Number
862.1155
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Classification Product Code
JHI
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Date Received
03/12/1996
Decision Date
04/25/1996
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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