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FDA 510(k) Application Details - K993839
Device Classification Name
Extractable Antinuclear Antibody, Antigen And Control
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510(K) Number
K993839
Device Name
Extractable Antinuclear Antibody, Antigen And Control
Applicant
TRINITY BIOTECH USA
2823 GIRTS RD.
JAMESTOWN, NY 14702 US
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Contact
WAYNE KVETKOSKY
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Regulation Number
866.5100
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Classification Product Code
LLL
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Date Received
11/12/1999
Decision Date
01/12/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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