Cleared Traditional

K993466 - WAKO L-TYPE TRIGLYCERIDE TEST

K993466 is an FDA 510(k) clearance for WAKO L-TYPE TRIGLYCERIDE TEST, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K993466 · Wako Chemicals USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
27d
Days
Class 1
Risk

K993466 is an FDA 510(k) clearance for the WAKO L-TYPE TRIGLYCERIDE TEST. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 27 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K993466

510(k) Number K993466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1999
Decision Date November 09, 1999
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
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 K993466.
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