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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 K980819
Device Name BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS
Applicant
Biocircuits Corp.
1324 Chesapeake Terr.
Sunnyvale,  CA  94089
Applicant Contact SHEILA J RAMERMAN
Correspondent
Biocircuits Corp.
1324 Chesapeake Terr.
Sunnyvale,  CA  94089
Correspondent Contact SHEILA J RAMERMAN
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Code
JJY  
Date Received03/03/1998
Decision Date 04/03/1998
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
Predetermined Change
Control Plan Authorized		 No
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