Cleared Traditional

URINALYSIS REAGENT STRIPS (10 PARAMETERS)

K993850 · International Newtech Development, Inc. · Chemistry
Jan 2000
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K993850 is an FDA 510(k) clearance for the URINALYSIS REAGENT STRIPS (10 PARAMETERS), a Diazo (colorimetric), Nitrite (urinary, Non-quant) (Class I — General Controls, product code JMT), submitted by International Newtech Development, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on January 3, 2000, 52 days after receiving the submission on November 12, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1510.

Submission Details

510(k) Number K993850 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1999
Decision Date January 03, 2000
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JMT — Diazo (colorimetric), Nitrite (urinary, Non-quant)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1510

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