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FDA 510(k) Application Details - K954575
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
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510(K) Number
K954575
Device Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant
ABBOTT LABORATORIES
100 ABBOTT MALL
BUFFALO, NY 14225 US
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Contact
JOANNE RUPPRECHT
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Regulation Number
866.3780
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Classification Product Code
LGD
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Date Received
10/02/1995
Decision Date
08/16/1996
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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