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FDA 510(k) Application Details - K974169
Device Classification Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
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510(K) Number
K974169
Device Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Applicant
WIESLAB AB
1306 BAILES LN.
SUITE F
FREDERICK, MD 21701 US
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Contact
WILLIAM L BOTELER
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Regulation Number
866.5660
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Classification Product Code
DBL
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More FDA Info for this Product Code
Date Received
11/05/1997
Decision Date
02/17/1998
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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