Cleared Traditional

URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING

K001810 · Flexsite Diagnostics, Inc. · Chemistry

Aug 2000

Decision

60d

Days

Class 1

Risk

About This 510(k) Submission

K001810 is an FDA 510(k) clearance for the URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING, a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR), submitted by Flexsite Diagnostics, Inc. (Washington, US). The FDA issued a Cleared decision on August 14, 2000, 60 days after receiving the submission on June 15, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number	K001810 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2000
Decision Date	August 14, 2000
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF