Cleared Traditional

K993925 - WAKO L-TYPE UN TEST

K993925 is an FDA 510(k) clearance for WAKO L-TYPE UN TEST, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K993925 · Wako Chemicals USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
137d
Days
Class 2
Risk

K993925 is an FDA 510(k) clearance for the WAKO L-TYPE UN TEST. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on April 3, 2000 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K993925

510(k) Number K993925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1999
Decision Date April 03, 2000
Days to Decision 137 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
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDQ Device Classification - Class 2, Special Controls

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 106
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K993925.
RAICHEM BUN RATE REAGENT
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UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
K002694 · Diagnostic Chemicals , Ltd. · Sep 2000
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
K993178 · Diagnostic Chemicals , Ltd. · Oct 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
K992800 · Sigma Diagnostics, Inc. · Sep 1999
BUN, MODEL BU 104-01
K990980 · A.P. Total Care, Inc. · May 1999