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510(k) Data Aggregation
K Number
K961062Device Name
FLEXSURE OBT
Manufacturer
SMITHKLINE DIAGNOSTICS, INC.
Date Cleared
1996-11-06
(233 days)
Product Code
KHE
Regulation Number
864.6550Why did this record match?
Applicant Name (Manufacturer) :
SMITHKLINE DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FlexSure ® OBT (Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin from blood in fecal samples. Fecal occult blood tests are useful screening aids for detecting primarily lower gastrointestinal (g.i.) disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. FlexSure ® OBT is recommended for use by health professionals as part of routine physical examinations or when lower g.i. disorders are suspected.
Device Description
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