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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K963770
Device Name BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY 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 Number862.1660
Classification Product Code
JJY  
Subsequent Product Code
DHA  
Date Received09/19/1996
Decision Date 12/05/1996
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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