Cleared Traditional

K843180 - SALICYLATE TEST

K843180 is the FDA 510(k) clearance for SALICYLATE TEST by Sclavo, Inc.. It is a Class 2 Toxicology device (product code DKJ) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K843180 · Sclavo, Inc. · Toxicology device
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Sep 1984
Decision
25d
Days
Class 2
Risk

K843180 is an FDA 510(k) clearance for the SALICYLATE TEST. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3830 - the FDA toxicology device 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 Sclavo, Inc. devices

Submission Details

510(k) Number K843180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1984
Decision Date September 07, 1984
Days to Decision 25 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 87d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKJ Colorimetry, Salicylate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3830
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKJ Colorimetry, Salicylate

All 22
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K843180.
SALICYLATE REAGENT SET
K861615 · Sterling Diagnostics, Inc. · May 1986
TDX SALICYLATE
K844070 · Abbott Laboratories · Nov 1984
SALICYLATE ASSAY KIT
K842158 · Diagnostic Chemicals, Ltd. (Usa) · Oct 1984
DETERMIN. OF SALICYLATE IN SERUM/PLAST
K840243 · Sigma Chemical Co. · Mar 1984
PARAMAX SALICYLATE REAGENT
K833003 · American Dade · Oct 1983
SALICYLATE ASSAY KIT
K831336 · Quantimetrix Corp. · Jul 1983