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510(k) K820252

TBG DIAGNOSTIC KIT by Diagnostic Reagents, Inc. — Product Code CEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1982
Date Received
January 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroxine-Binding Globulin
Device Class
Class II
Regulation Number
862.1685
Review Panel
CH
Submission Type

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