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FDA 510(k) Application Details - K093101
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Rubella
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510(K) Number
K093101
Device Name
Enzyme Linked Immunoabsorbent Assay, Rubella
Applicant
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI, FL 33127 US
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Contact
Glenn Gerstenfeld
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Regulation Number
866.3510
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Classification Product Code
LFX
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More FDA Info for this Product Code
Date Received
10/01/2009
Decision Date
01/21/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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