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510(k) K020548

FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 by Monobind — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2002
Date Received
February 19, 2002
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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