FDA 510(k), K040107, CYTO-CHEX BCT

FDA 510(k), K040107, CYTO-CHEX BCT

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510(K) Number: K040107
Device Name: CYTO-CHEX BCT
Manufacturer: KERRIE OETTER
Device Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation Number: JKA
Classification Product Code: 01/20/2004
Date Received: 07/27/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology

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