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FDA 510(k) Application Details - K981867
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
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510(K) Number
K981867
Device Name
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Applicant
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI, FL 33127 US
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Contact
LYNN STIRLING
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Regulation Number
866.3900
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Classification Product Code
LFY
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More FDA Info for this Product Code
Date Received
05/28/1998
Decision Date
09/28/1998
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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