Cleared Traditional

K941063 - DNA TRIGLYCERIDE PROCEDURE

K941063 is an FDA 510(k) clearance for DNA TRIGLYCERIDE PROCEDURE, manufactured by Data Medical Associates, Inc.. The device is a Class 1 Chemistry device with product code JGY cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K941063 · Data Medical Associates, Inc. · Chemistry device
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Jul 1994
Decision
134d
Days
Class 1
Risk

K941063 is an FDA 510(k) clearance for the DNA TRIGLYCERIDE PROCEDURE. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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 Data Medical Associates, Inc. devices

FDA 510(k) Submission Details - K941063

510(k) Number K941063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date July 20, 1994
Days to Decision 134 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
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

JGY Device Classification - Class 1, General Controls

Product Code JGY Colorimetric Method, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
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 - JGY Colorimetric Method, Triglycerides

All 18
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