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510(k) Data Aggregation
K Number
K071242Device Name
DBEST ONE STEP OCCULT BLOOD TEST KITS
Manufacturer
AMERITEK USA, INC.
Date Cleared
2008-03-06
(308 days)
Product Code
KHE
Regulation Number
864.6550Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest One Step Occult Blood Test Kits is a simple immunochromatographic assay for rapid, qualitative detection of fecal occult blood by laboratories or physicians office. It is useful as a diagnostic test kit to aid for detection of bleeding caused by a number of gastrointestinal disorders, such as diverticulitis, colitis, polyps and colorectal cancer. dBest One Step Occult Blood Test Kit is recommended for use in 1) Routine physical examinations, 2) Hospital monitoring for gastrointestinal bleeding and 3) Screening for colorectal cancer
Device Description
dBest One Step Occult Blood Test Kits is a simple immunochromatographic assay for rapid, qualitative detection of fecal occult blood.
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K Number
K061257Device Name
DBEST HCG PANEL TEST KIT
Manufacturer
AMERITEK USA, INC.
Date Cleared
2007-05-04
(365 days)
Product Code
JHI, LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
AMERITEK USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
dBest hCG Panel Test Kit is a simple one step immunochromatographic assay for rapid, semi-quantitative detection of hCG in urine with cutoffs of 25, 100, 500, 2,000 and 1.0,000 mlU/mL. The dBest hCG Panel Test Kits are for professional, physician's offices laboratory and OTC use, for the early detection of pregnancy.
Device Description
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