Cleared Traditional

DIASCREEN REAGENT STRIPS

K981555 · Chronimed, Inc. · Chemistry
Jun 1998
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K981555 is an FDA 510(k) clearance for the DIASCREEN REAGENT STRIPS, a Test, Urine Leukocyte (Class I — General Controls, product code LJX), submitted by Chronimed, Inc. (Edina, US). The FDA issued a Cleared decision on June 1, 1998, 31 days after receiving the submission on May 1, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7675.

Submission Details

510(k) Number K981555 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1998
Decision Date June 01, 1998
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LJX — Test, Urine Leukocyte
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.7675

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