FDA 510(k) Application Details - K874328

Device Classification Name Lymphocyte Separation Medium

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510(K) Number K874328
Device Name Lymphocyte Separation Medium
Applicant E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON, DE US
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Contact EDWARD R KIMMELMAN
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Regulation Number 864.8500

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Classification Product Code JCF
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Date Received 10/22/1987
Decision Date 02/16/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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