FDA 510(k) Application Details - K834241

Device Classification Name Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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510(K) Number K834241
Device Name Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant APPLE DIAGNOSTIC PRODUCTS

, US
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Regulation Number 866.5100

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Classification Product Code DHN
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Date Received 12/06/1983
Decision Date 04/04/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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