FDA 510(k) Application Details - K861499

Device Classification Name Complement C1q, Antigen, Antiserum, Control

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510(K) Number K861499
Device Name Complement C1q, Antigen, Antiserum, Control
Applicant BIOSTAR MEDICAL PRODUCTS, INC.
JERRY W. BERKSTRESSER
738 PEARL STREET
DENVER, CO US
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Regulation Number 866.5240

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Classification Product Code DAK
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Date Received 04/23/1986
Decision Date 06/20/1986
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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