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510(k) K760077

TEST, RIA, SERUM DIGOXIN by Smithkline Diagnostics, Inc. — Product Code DND

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1976
Date Received
June 18, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Device Class
Class II
Regulation Number
862.3300
Review Panel
TX
Submission Type

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