Cleared Traditional

K873425 - EASY-TEST SALICYLATE (SAL) #16691

K873425 is the FDA 510(k) clearance for EASY-TEST SALICYLATE (SAL) #16691 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code DKJ) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K873425 · Em Diagnostic Systems, Inc. · Chemistry device
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Oct 1987
Decision
65d
Days
Class 2
Risk

K873425 is an FDA 510(k) clearance for the EASY-TEST SALICYLATE (SAL) #16691. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on October 29, 1987 after a review of 65 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K873425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1987
Decision Date October 29, 1987
Days to Decision 65 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
23d faster than avg
Panel avg: 88d · This submission: 65d
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 K873425.
ABUSCREEN ONLINE(R) CALIBRATORS
K946000 · Roche Diagnostic Systems, Inc. · Jan 1995
DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
K904301 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)
K902356 · Eastman Kodak Company · Jul 1990
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
K872321 · Em Diagnostic Systems, Inc. · Aug 1987
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
K872330 · Em Diagnostic Systems, Inc. · Jul 1987
SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71
K870336 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1987