Cleared Traditional

SERIM LEUKOCYTE ESTERASE TEST STRIPS

K000578 · Serim Research Corp. · Hematology
May 2000
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K000578 is an FDA 510(k) clearance for the SERIM LEUKOCYTE ESTERASE TEST STRIPS, a Test, Urine Leukocyte (Class I — General Controls, product code LJX), submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on May 5, 2000, 73 days after receiving the submission on February 22, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7675.

Submission Details

510(k) Number K000578 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2000
Decision Date May 05, 2000
Days to Decision 73 days
Submission Type Traditional
Review Panel Hematology (HE)
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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