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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, For Clinical Use
510(k) Number K952719
Device Name BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
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 Number862.2560
Classification Product Code
KHO  
Date Received06/15/1995
Decision Date 11/22/1995
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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