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510(k) K991610

ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. by Zeus Scientific, Inc. — Product Code DDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1999
Date Received
May 10, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thyroglobulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

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