Cleared Traditional

K813185 - SALICYLATE STAT-PAK

K813185 is an FDA 510(k) clearance for SALICYLATE STAT-PAK, manufactured by Clin Tech Diagnostics Corp.. The device is a Class 2 Toxicology device with product code DKJ cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K813185 · Clin Tech Diagnostics Corp. · Toxicology device
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Nov 1981
Decision
8d
Days
Class 2
Risk

K813185 is an FDA 510(k) clearance for the SALICYLATE STAT-PAK. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Clin Tech Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981 after a review of 8 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.

FDA 510(k) Submission Details - K813185

510(k) Number K813185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1981
Decision Date November 24, 1981
Days to Decision 8 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
79d faster than avg
Panel avg: 87d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKJ Device Classification - Class 2, Special Controls

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.

K813185 · SALICYLATE STAT-PAK
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