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FDA 510(k) Application Details - K982027
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
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510(K) Number
K982027
Device Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant
DIASORIN, INC.
9175 GUIFORD RD.
COLUMBIA, MD 21046 US
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Contact
JUDITH J SMITH
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Regulation Number
866.3175
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Classification Product Code
LFZ
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Date Received
06/02/1998
Decision Date
11/25/1998
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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