Cleared Traditional

K964715 - PARAMAX SALICYLATE REAGENT

K964715 is an FDA 510(k) clearance for PARAMAX SALICYLATE REAGENT, manufactured by Dade Intl., Inc.. The device is a Class 2 Toxicology device with product code DKJ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K964715 · Dade Intl., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
151d
Days
Class 2
Risk

K964715 is an FDA 510(k) clearance for the PARAMAX SALICYLATE REAGENT. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on April 25, 1997 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dade Intl., Inc. devices

FDA 510(k) Submission Details - K964715

510(k) Number K964715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date April 25, 1997
Days to Decision 151 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 87d · This submission: 151d
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.

Regulatory Peers - DKJ Colorimetry, Salicylate

All 26
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K964715.
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
K011878 · Syva Co. · Aug 2001
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
K981872 · Diagnostic Chemicals , Ltd. · Jun 1998
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
K980032 · Diagnostic Chemicals , Ltd. · Mar 1998
SALICYLATE ASSAY
K961131 · Diagnostic Reagents, Inc. · Apr 1996
AXSYM SALICYLATE
K951290 · Abbott Laboratories · Aug 1995
ABUSCREEN ONLINE(R) CALIBRATORS
K946000 · Roche Diagnostic Systems, Inc. · Jan 1995