FDA 510(k) Application Details - K894538

Device Classification Name Fc, Antigen, Antiserum, Control

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510(K) Number K894538
Device Name Fc, Antigen, Antiserum, Control
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
2000 LAKE HAZELTINE DR.
CHASKA, MN US
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Contact JAN NEBELSICK
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Regulation Number 866.5530

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Classification Product Code DBN
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Date Received 07/20/1989
Decision Date 08/04/1989
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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