Cleared Traditional

URI-TEST 3, INLAB REAGENT STRIPS-URINAL

K831498 · Laprol Scientific, Inc. · Chemistry

Jun 1983

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K831498 is an FDA 510(k) clearance for the URI-TEST 3, INLAB REAGENT STRIPS-URINAL, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Laprol Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983, 42 days after receiving the submission on May 11, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number	K831498 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 1983
Decision Date	June 22, 1983
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—