Cleared Traditional

K821315 - DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM

K821315 is an FDA 510(k) clearance for DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM, manufactured by The Dow Chemical Co.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K821315 · The Dow Chemical Co. · Chemistry device
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May 1982
Decision
20d
Days
Class 1
Risk

K821315 is an FDA 510(k) clearance for the DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on May 24, 1982 after a review of 20 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 The Dow Chemical Co. devices

FDA 510(k) Submission Details - K821315

510(k) Number K821315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date May 24, 1982
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
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 K821315.
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ULTRACHEM TRI-ES
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K812589 · Harleco · Sep 1981
SPIN-CHEM TRIGLYCERIDES REAGENT
K812471 · Smithkline Diagnostics, Inc. · Sep 1981