Cleared Traditional

K850935 - CHLORIDE

K850935 is an FDA 510(k) clearance for CHLORIDE, manufactured by Dilab, Inc.. The device is a Class 2 Chemistry device with product code CHJ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K850935 · Dilab, Inc. · Chemistry device
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Jun 1985
Decision
95d
Days
Class 2
Risk

K850935 is an FDA 510(k) clearance for the CHLORIDE. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 10, 1985 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dilab, Inc. devices

FDA 510(k) Submission Details - K850935

510(k) Number K850935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 10, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHJ Device Classification - Class 2, Special Controls

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 49
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K850935.
AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271
K860662 · Amresco, Inc. · Mar 1986
CHLORIDE REAGENT
K852169 · Pointe Scientific, Inc., · Aug 1985
CHLORIDE ASSAY KIT
K852058 · Diagnostic Chemicals, Ltd. (Usa) · Jul 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