FDA 510(k) Application Details - K851285

Device Classification Name Albumin, Antigen, Antiserum, Control

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510(K) Number K851285
Device Name Albumin, Antigen, Antiserum, Control
Applicant COOPER BIOMEDICAL, INC.
ONE TECHNOLOGY COURT
MALVERN, PA US
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Contact AMIRAM DANIEL
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Regulation Number 866.5040

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Classification Product Code DCF
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Date Received 04/01/1985
Decision Date 06/17/1985
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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