FDA 510K (K023046) SST SALIVA SUPPORTING TABLETS

FDA 510K (K023046) SST SALIVA SUPPORTING TABLETS

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Device Classification Name    Stains, Chemical Solution
510(k) Number    K023046
Device Name    SST SALIVA SUPPORTING TABLETS
Applicant    SINCLAIR PHARMACEUTICALS, LTD.
Regulation Number    864.1850
Classification Product Code    LED  
Date Received    09/12/2002
Decision Date    12/02/2002
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Hematology
510k Review Panel    Pathology

Total pages: 61
Fully redacted pages: 13
Content pages: 48

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