FDA 510(k) Application Details - K840974

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

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510(K) Number K840974
Device Name Total Spinal-Fluid, Antigen, Antiserum, Control
Applicant SOMAS MEDICAL INDUSTRIES, INC.

, US
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Regulation Number 866.5860

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Classification Product Code DFI
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Date Received 03/06/1984
Decision Date 04/05/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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