FDA 510(k) Application Details - K942326

Device Classification Name Complement C5, Antigen, Antiserum, Control

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510(K) Number K942326
Device Name Complement C5, Antigen, Antiserum, Control
Applicant JAY H. GELLER
2425 WEST OLYMPIC BLVD.
SUITE 600
SANTA MONICA, CA US
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Contact JAY H GELLER
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Regulation Number 866.5240

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Classification Product Code DAY
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Date Received 05/13/1994
Decision Date 08/24/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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