Cleared Traditional

K770993 - TRIGLYCERIDE REAGENT SET

K770993 is the FDA 510(k) clearance for TRIGLYCERIDE REAGENT SET by Macomb Chemical Co.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K770993 · Macomb Chemical Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1977
Decision
93d
Days
Class 1
Risk

K770993 is an FDA 510(k) clearance for the TRIGLYCERIDE REAGENT SET. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Macomb Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 2, 1977 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 Macomb Chemical Co. devices

Submission Details

510(k) Number K770993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1977
Decision Date September 02, 1977
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 116
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K770993.
TRIGLYCERIDE INSTRUMENT APPLICATION
K780172 · Harleco · Mar 1978
A-GENT TRIGLYCERIDES
K771608 · Abbott Laboratories · Sep 1977
AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI
K771004 · Miles Laboratories, Inc. · Sep 1977
MULTISTAT III TRIGLYCERIDE TEST
K771472 · Instrumentation Laboratory CO · Sep 1977
TRIGLYCERIDE ENZYMATIC METHOD
K770841 · Union Carbide Corp. · Jul 1977
ENZYMATIC TRIGLYCERIDES (END POINT)
K761200 · Beckman Instruments, Inc. · Dec 1976