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510(k) K924186

LPIA-FERRITIN ASSAY by Seradyn, Inc. — Product Code DEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1992
Date Received
August 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5425
Review Panel
IM
Submission Type

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