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510(k) K953066

SERODIA ATG by Fujirebio America, Inc. — Product Code DDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1995
Date Received
June 30, 1995
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

Other clearances by Fujirebio America, Inc.

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  • K930486 — QUANTA LITE(TM) THYROID T ELISA (March 15, 1993)
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