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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K981243
Device Name BIOSTRIDE FREE T4 EIA TEST KIT
Applicant
BIOSTRIDE DIAGNOSTICS, INC.
1206 SESAME DR.
SUNNYVALE,  CA  94087
Applicant Contact JANIS FREESTONE
Correspondent
BIOSTRIDE DIAGNOSTICS, INC.
1206 SESAME DR.
SUNNYVALE,  CA  94087
Correspondent Contact JANIS FREESTONE
Regulation Number862.1695
Classification Product Code
CEC  
Date Received04/06/1998
Decision Date 06/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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