Cleared Traditional

K833082 - REAGENT SET TRIGLYCERIDES GPO

K833082 is an FDA 510(k) clearance for REAGENT SET TRIGLYCERIDES GPO, 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 74-day FDA review.

K833082 · Boehringer Mannheim Corp. · Chemistry device
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Nov 1983
Decision
74d
Days
Class 1
Risk

K833082 is an FDA 510(k) clearance for the REAGENT SET TRIGLYCERIDES GPO. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on November 25, 1983 after a review of 74 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 - K833082

510(k) Number K833082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1983
Decision Date November 25, 1983
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
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 K833082.
TRIGLYCERIDE REAGENT SET
K841062 · Medical Specialties, Inc. · May 1984
TRIGLYCERIDES REAGENT
K840780 · American Dade · Apr 1984
LIQUID STABLE TRIGLYCERIDES REAGENT SET
K834518 · Medical Analysis Systems, Inc. · Mar 1984
LIPASE HYDROLYSIS/GLYCEROL KINASE
K832871 · Pointe Scientific, Inc., · Oct 1983
SERALYZER TRIGLYCERIDES REAGENT STRIPS
K832684 · Miles Laboratories, Inc. · Oct 1983
ENZYMATIC TRIGLYCERIDES #2000
K832444 · Stanbio Laboratory · Aug 1983