URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING

Indicator Method, Protein Or Albumin (urinary, Non-quant.)

FLEXSITE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Flexsite Diagnostics, Inc. with the FDA for Urisite Urine Collection Kit For Microalbumin/creatinine Testing.

Pre-market Notification Details

Device IDK001810
510k NumberK001810
Device Name:URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
ClassificationIndicator Method, Protein Or Albumin (urinary, Non-quant.)
Applicant FLEXSITE DIAGNOSTICS, INC. 1900 K STREET, N.W. Washington,  DC  20006 -1108
ContactDonald R Stone
CorrespondentDonald R Stone
FLEXSITE DIAGNOSTICS, INC. 1900 K STREET, N.W. Washington,  DC  20006 -1108
Product CodeJIR  
CFR Regulation Number862.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-15
Decision Date2000-08-14

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