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Flexsite Diagnostics, Inc.
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URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING is an FDA 510(k)-cleared medical device (K001810) manufactured by Flexsite Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 13, 2000. Regulation: 8.