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510(k) K934012

FT4 RADIOIMMUNOASSAY by Immunotech S.A. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1993
Date Received
August 18, 1993
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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  • K950626 — OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES (May 5, 1995)
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  • K911153 — MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT (June 18, 1991)
  • K910411 — MICROZYME TSH ENZYME IMMUNOASSAY KIT (April 3, 1991)

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