Cleared Traditional

K873049 - TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL

K873049 is an FDA 510(k) clearance for TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K873049 · Boehringer Mannheim Corp. · Chemistry device
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Aug 1987
Decision
24d
Days
Class 1
Risk

K873049 is an FDA 510(k) clearance for the TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 28, 1987 after a review of 24 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K873049

510(k) Number K873049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date August 28, 1987
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 116
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K873049.
A-GENT TRIGLLYCERIDES GPO
K874187 · Abbott Laboratories · Jan 1988
TRIGLYERIDES TEST KIT
K874584 · Ciba Corning Diagnostics Corp. · Jan 1988
BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR
K873160 · Biotrol, USA, Inc. · Sep 1987
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
K871508 · Trace Scientific , Ltd. · May 1987
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
K871509 · Trace Scientific , Ltd. · May 1987
ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD
K871301 · American Monitor Corp. · Apr 1987