FDA 510(k) Application Details - K781103

Device Classification Name Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

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510(K) Number K781103
Device Name Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
Applicant MEDISHIELD, INC.

, US
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Regulation Number 864.7340

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Classification Product Code DAT
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Date Received 07/03/1978
Decision Date 09/27/1978
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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