Cleared Traditional

K852058 - CHLORIDE ASSAY KIT

K852058 is the FDA 510(k) clearance for CHLORIDE ASSAY KIT by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K852058 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Jul 1985
Decision
64d
Days
Class 2
Risk

K852058 is an FDA 510(k) clearance for the CHLORIDE ASSAY KIT. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on July 12, 1985 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K852058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date July 12, 1985
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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 - CHJ Mercuric Thiocyanate, Colorimetry, Chloride

All 40
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K852058.
CHLORIDE PROCEDURE
K861674 · Data Medical Associates, Inc. · Jul 1986
AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271
K860662 · Amresco, Inc. · Mar 1986
CHLORIDE REAGENT
K852169 · Pointe Scientific, Inc., · Aug 1985
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
K850334 · Roche Diagnostic Systems, Inc. · Mar 1985
SCLAVO CHLORIDE TEST
K843740 · Sclavo, Inc. · Oct 1984
CHLORIDE TEST KIT
K842011 · Mallinckrodt Critical Care · Jun 1984