FDA 510(k) Application Details - K772075

Device Classification Name Complement C5, Antigen, Antiserum, Control

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510(K) Number K772075
Device Name Complement C5, Antigen, Antiserum, Control
Applicant GELMAN INSTRUMENT CO.

, US
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Regulation Number 866.5240

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Classification Product Code DAY
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Date Received 11/03/1977
Decision Date 02/03/1978
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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