Cleared Traditional

TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE

K852611 · Miles Laboratories, Inc. · Chemistry
Sep 1985
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K852611 is an FDA 510(k) clearance for the TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE, a Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (Class I — General Controls, product code CDM), submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on September 3, 1985, 76 days after receiving the submission on June 19, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1785.

Submission Details

510(k) Number K852611 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1985
Decision Date September 03, 1985
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDM — Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1785

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