FDA 510(k) Application Details - K832821

Device Classification Name Total Spinal-Fluid, Antigen, Antiserum, Control

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510(K) Number K832821
Device Name Total Spinal-Fluid, Antigen, Antiserum, Control
Applicant INTL. DIAGNOSTIC TECHNOLOGY

, US
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Regulation Number 866.5860

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Classification Product Code DFI
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Date Received 08/19/1983
Decision Date 10/14/1983
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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