Cleared Traditional

K792234 - SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES

K792234 is an FDA 510(k) clearance for SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES, 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 21-day FDA review.

K792234 · Boehringer Mannheim Corp. · Chemistry device
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Nov 1979
Decision
21d
Days
Class 1
Risk

K792234 is an FDA 510(k) clearance for the SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES. 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 27, 1979 after a review of 21 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 - K792234

510(k) Number K792234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1979
Decision Date November 27, 1979
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 K792234.
ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC
K800649 · Reagents Applications, Inc. · May 1980
SIGMA PROCEDURE & REAGENT SYSTEM #335-UV
K800301 · Sigma Chemical Co. · Mar 1980
CHEM-STRATE TRIGLYCERIDE
K792480 · General Diagnostics · Dec 1979
COULTER ACCU-ZYME II ENZYMATIC REAGENT
K791640 · Coulter Electronics, Inc. · Sep 1979
ENZYMATIC TRIGLYCERIDES-S.V.R.
K790773 · Calbiochem-Behring Corp. · Jun 1979
REAGENT KIT, TRIGLYCERIDES
K781939 · Beckman Instruments, Inc. · Jan 1979