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510(k) K963139

OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT by Olympus America, Inc. — Product Code DDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1997
Date Received
August 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transferrin, Rhodamine, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
Submission Type

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