Cleared Traditional

K863585 - CHLORIDE PROCEDURE

K863585 is the FDA 510(k) clearance for CHLORIDE PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K863585 · Data Medical Associates, Inc. · Chemistry device
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Oct 1986
Decision
31d
Days
Class 2
Risk

K863585 is an FDA 510(k) clearance for the CHLORIDE PROCEDURE. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on October 16, 1986 after a review of 31 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K863585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1986
Decision Date October 16, 1986
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 K863585.
CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS
K872511 · Catachem, Inc. · Jul 1987
CHLORIDE TEST
K870630 · Sclavo, Inc. · Apr 1987
CHLORIDE REAGENT
K864713 · Sigma Diagnostics, Inc. · Dec 1986
RAICHEM(TM) CHLORIDE REAGENT
K863620 · Reagents Applications, Inc. · Sep 1986
CLOROFAST
K863061 · J. D. Assoc. · Sep 1986
CHLORIDE PROCEDURE
K861674 · Data Medical Associates, Inc. · Jul 1986