Cleared Traditional

K833003 - PARAMAX SALICYLATE REAGENT

K833003 is the FDA 510(k) clearance for PARAMAX SALICYLATE REAGENT by American Dade. It is a Class 2 Chemistry device (product code DKJ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K833003 · American Dade · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
77d
Days
Class 2
Risk

K833003 is an FDA 510(k) clearance for the PARAMAX SALICYLATE REAGENT. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3830 - 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 American Dade devices

Submission Details

510(k) Number K833003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date October 28, 1983
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
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 Chemistry 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 K833003.
SALICYLATE ASSAY KIT
K842158 · Diagnostic Chemicals, Ltd. (Usa) · Oct 1984
SALICYLATE TEST
K843180 · Sclavo, Inc. · Sep 1984
DETERMIN. OF SALICYLATE IN SERUM/PLAST
K840243 · Sigma Chemical Co. · Mar 1984
SALICYLATE ASSAY KIT
K831336 · Quantimetrix Corp. · Jul 1983
TOXI-LAB RAPID SCREEN
K823523 · Marion Laboratories, Inc. · Jan 1983