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FDA 510(k) Application Details - K180975
Device Classification Name
Extractable Antinuclear Antibody, Antigen And Control
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510(K) Number
K180975
Device Name
Extractable Antinuclear Antibody, Antigen And Control
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego, CA 92131-1638 US
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Contact
Roger Albesa
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Regulation Number
866.5100
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Classification Product Code
LLL
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Date Received
04/13/2018
Decision Date
06/25/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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