Cleared Traditional

K965103 - WINMAX SOFTWARE SYSTEMS

K965103 is an FDA 510(k) clearance for WINMAX SOFTWARE SYSTEMS, manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K965103 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
140d
Days
Class 1
Risk

K965103 is an FDA 510(k) clearance for the WINMAX SOFTWARE SYSTEMS. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K965103

510(k) Number K965103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1996
Decision Date May 09, 1997
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 88d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

JJF Device Classification - Class 1, General Controls

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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.

Regulatory Peers - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 44
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