FDA 510(k) Application Details - K924892

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

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510(K) Number K924892
Device Name Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
Applicant ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM, NC US
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Contact RON SANLYAL
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Regulation Number 864.7340

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Classification Product Code DAT
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Date Received 09/29/1992
Decision Date 04/21/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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