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510(k) K931600

CHEMILUMINESCENCE FREE T3 IMMUNOASSAY by Nichols Institute — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1993
Date Received
April 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Triiodothyronine
Device Class
Class II
Regulation Number
862.1710
Review Panel
CH
Submission Type

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