Cleared Traditional

K873656 - MEDATRON CUVETTE DISC

K873656 is an FDA 510(k) clearance for MEDATRON CUVETTE DISC, manufactured by Medatron, Inc.. The device is a Class 1 Chemistry device with product code JRI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K873656 · Medatron, Inc. · Chemistry device
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Dec 1987
Decision
95d
Days
Class 1
Risk

K873656 is an FDA 510(k) clearance for the MEDATRON CUVETTE DISC. Classified as Cuvette, Thermostated (product code JRI), Class I - General Controls.

Submitted by Medatron, Inc. (Brookfield, US). The FDA issued a Cleared decision on December 14, 1987 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - 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 Medatron, Inc. devices

FDA 510(k) Submission Details - K873656

510(k) Number K873656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1987
Decision Date December 14, 1987
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

JRI Device Classification - Class 1, General Controls

Product Code JRI Cuvette, Thermostated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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.