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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K953837
Device Name BIOCIRCUITS IOS T4 TEST CARTRIDGE
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 Number862.1700
Classification Product Code
KLI  
Subsequent Product Code
JJY  
Date Received08/15/1995
Decision Date 11/20/1995
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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