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510(k) K971141

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM by Dade Chemistry Systems, Inc. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1997
Date Received
March 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

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