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FDA 510(k) Application Details - K052662
Device Classification Name
Radioimmunoassay, Follicle-Stimulating Hormone
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510(K) Number
K052662
Device Name
Radioimmunoassay, Follicle-Stimulating Hormone
Applicant
IND DIAGNOSTIC INC.
1629 FOSTERS WAY
DELTA, B.C. V3M 6S7 CA
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Contact
JASON PENG
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Regulation Number
862.1300
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Classification Product Code
CGJ
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More FDA Info for this Product Code
Date Received
09/27/2005
Decision Date
11/30/2005
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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