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510(k) K924197

ZORBA(TM) IGG REMOVAL REAGENT by Zeus Scientific, Inc. — Product Code DEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1992
Date Received
August 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
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