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FDA 510(k) Application Details - K051733
Device Classification Name
Enzyme Immunoassay, Cortisol, Salivary
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510(K) Number
K051733
Device Name
Enzyme Immunoassay, Cortisol, Salivary
Applicant
DRG INTL., INC.
150 CHERRY LANE RD.
EAST STROUDSBURG, PA 18301 US
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Contact
Gary Lehnus
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Regulation Number
862.1205
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Classification Product Code
NHG
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More FDA Info for this Product Code
Date Received
06/28/2005
Decision Date
12/07/2005
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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