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FDA 510(k) Application Details - K042629
Device Classification Name
Anti-Sm Antibody, Antigen And Control
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510(K) Number
K042629
Device Name
Anti-Sm Antibody, Antigen And Control
Applicant
SWEDEN DIAGNOSTICS (GERMANY) GMBH
MUNZINGER STRASSE 7
FREIBURG D-79111 DE
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Contact
SABINE KLUGBAUER
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Regulation Number
866.5100
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Classification Product Code
LKP
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More FDA Info for this Product Code
Date Received
09/27/2004
Decision Date
12/08/2004
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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