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FDA 510(k) Application Details - K974552
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Rubeola
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510(K) Number
K974552
Device Name
Enzyme Linked Immunoabsorbent Assay, Rubeola
Applicant
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI, FL 33127 US
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Contact
LYNNE STIRLING
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Regulation Number
866.3520
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Classification Product Code
LJB
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More FDA Info for this Product Code
Date Received
12/04/1997
Decision Date
01/28/1998
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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