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FDA 510(k) Application Details - K961765
Device Classification Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
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510(K) Number
K961765
Device Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant
IMMUNO PROBE, INC.
1306F BAILES LN.
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
MOB
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More FDA Info for this Product Code
Date Received
05/07/1996
Decision Date
08/19/1996
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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