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510(k) K936010

THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY by Biomerica, Inc. — Product Code DDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
December 16, 1993
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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