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FDA 510(k) Application Details - K040407
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
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510(K) Number
K040407
Device Name
Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
Applicant
IMMUNETICS, INC.
27 DRYDOCK AVENUE
BOSTON, MA 02210 US
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Contact
ANDREW LEVIN
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Regulation Number
000.0000
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Classification Product Code
NRL
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More FDA Info for this Product Code
Date Received
02/17/2004
Decision Date
06/03/2004
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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