Cleared Traditional

K760029 - ENZYMATIC TRIGLYCERIDE

K760029 is an FDA 510(k) clearance for ENZYMATIC TRIGLYCERIDE, manufactured by Harleco. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K760029 · Harleco · Chemistry device
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Sep 1976
Decision
93d
Days
Class 1
Risk

K760029 is an FDA 510(k) clearance for the ENZYMATIC TRIGLYCERIDE. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 15, 1976 after a review of 93 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 Harleco devices

FDA 510(k) Submission Details - K760029

510(k) Number K760029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1976
Decision Date September 15, 1976
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

CDT Device Classification - Class 1, General Controls

Product Code CDT Lipase Hydrolysis/glycerol Kinase Enzyme, 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 - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 134
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K760029.
TRIGLYCERIDE ENZYMATIC METHOD
K770841 · Union Carbide Corp. · Jul 1977
ENZYMATIC TRIGLYCERIDES (END POINT)
K761200 · Beckman Instruments, Inc. · Dec 1976
TRIGLYCERIDES TEST
K760713 · Boehringer Mannheim Corp. · Nov 1976
REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1
K760195 · Coulter Electronics, Inc. · Aug 1976
REAGENT, TRIGLYCERIDES
K760011 · The Dow Chemical Co. · Jul 1976