Cleared Traditional

K954977 - URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (FDA 510(k) Clearance)

Class I Chemistry device.

K954977 · Teco Diagnostics · Chemistry device
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Mar 1996
Decision
147d
Days
Class 1
Risk

K954977 is an FDA 510(k) clearance for the URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION). Classified as Refractometer For Clinical Use (product code JRE), Class I - General Controls.

Submitted by Teco Diagnostics (Placentia, US). The FDA issued a Cleared decision on March 11, 1996 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2800 - 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.

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Submission Details

510(k) Number K954977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date March 11, 1996
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JRE Refractometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2800
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.