Cleared Traditional

DBEST REAGENT STRIP FOR URINALYSIS

K973142 · Ameritek, Inc. · Chemistry
Oct 1997
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K973142 is an FDA 510(k) clearance for the DBEST REAGENT STRIP FOR URINALYSIS, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on October 20, 1997, 60 days after receiving the submission on August 21, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K973142 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1997
Decision Date October 20, 1997
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340

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