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510(k) Data Aggregation
K Number
K001810Device Name
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
Manufacturer
FLEXSITE DIAGNOSTICS, INC.
Date Cleared
2000-08-14
(60 days)
Product Code
JIR
Regulation Number
862.1645Why did this record match?
Applicant Name (Manufacturer) :
FLEXSITE DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K971919Device Name
EZCHEK/HBA BLOOD COLLECTION KIT
Manufacturer
FLEXSITE DIAGNOSTICS, INC.
Date Cleared
1997-09-05
(105 days)
Product Code
LCP
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
FLEXSITE DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For over-the-counter at home or doctor's office use to obtain a finger stick whole blood sample for laboratory to monitor long-term (4-8 weeks) blood sugar control in individuals with diabetes mellitus. Not indicated for diagnosis of diabetes mellitus.
Device Description
The device is a kit containing the materials required to collect a capillary blood sample from a finger-stick on a piece of filter paper and mail it to a laboratory for determination of its hemoglobin A16 %. The kit contains a lancet, an alcohol wipe, a test request form with filter paper, a biohazard bag, a return envelope with lifter papereturning a result to the patient and/or his/her doctor.
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