FDA 510(k) Application Details - K894573

Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control

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510(K) Number K894573
Device Name C-Reactive Protein, Antigen, Antiserum, And Control
Applicant IMMUNTECH A/S
DK-5210
ODENSE NV
DENMARK DA
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Contact BRIAN LUNDSTROM
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Regulation Number 866.5270

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Classification Product Code DCK
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Date Received 07/21/1989
Decision Date 08/10/1989
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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