FDA 510(k) Application Details - K812076

Device Classification Name Igd, Peroxidase, Antigen, Antiserum, Control

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510(K) Number K812076
Device Name Igd, Peroxidase, Antigen, Antiserum, Control
Applicant BIOTEST-SERUM-INSTITUT

, US
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Regulation Number 866.5510

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Classification Product Code DGH
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Date Received 07/22/1981
Decision Date 08/12/1981
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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