Cleared Traditional

REAGENT TESTS STRIP COMBINATIONS (K833521) - FDA 510(k) Clearance

Class I Chemistry device.

K833521 · Syn-Kit, Inc. · Chemistry device
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Jan 1984
Decision
92d
Days
Class 1
Risk

K833521 is an FDA 510(k) clearance for the REAGENT TESTS STRIP COMBINATIONS. Classified as Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.) (product code JJB), Class I - General Controls.

Submitted by Syn-Kit, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1115 - 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K833521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1983
Decision Date January 11, 1984
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJB Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1115
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.