Cleared Traditional

K822709 - URITEST 9, INLAB REAGENT STRIPS URINALY

K822709 is an FDA 510(k) clearance for URITEST 9, manufactured by Laprol Scientific, Inc.. The device is a Class 1 Chemistry device with product code JMA cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K822709 · Laprol Scientific, Inc. · Chemistry device
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Jan 1983
Decision
143d
Days
Class 1
Risk

K822709 is an FDA 510(k) clearance for the URITEST 9, INLAB REAGENT STRIPS URINALY. Classified as Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) (product code JMA), Class I - General Controls.

Submitted by Laprol Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1095 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Laprol Scientific, Inc. devices

FDA 510(k) Submission Details - K822709

510(k) Number K822709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date January 28, 1983
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

JMA Device Classification - Class 1, General Controls

Product Code JMA Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1095
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.