Cleared Traditional

K834333 - FLOW-PAC CHLORIDE REAGENT SET

K834333 is the FDA 510(k) clearance for FLOW-PAC CHLORIDE REAGENT SET by American Research Products Co.. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K834333 · American Research Products Co. · Chemistry device
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Feb 1984
Decision
71d
Days
Class 2
Risk

K834333 is an FDA 510(k) clearance for the FLOW-PAC CHLORIDE REAGENT SET. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by American Research Products Co. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 71 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 American Research Products Co. devices

Submission Details

510(k) Number K834333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date February 21, 1984
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K834333.
SCLAVO CHLORIDE TEST
K843740 · Sclavo, Inc. · Oct 1984
CHLORIDE TEST KIT
K842011 · Mallinckrodt Critical Care · Jun 1984
PARAMAX CHLORIDE REAGENT
K841047 · American Dade · Apr 1984
CHLORIDE REAGENT SET
K832438 · Amresco, Inc. · Jan 1984
TECH. RA-1000 SYS SERUM CHLORIDE
K833746 · Technicon Instruments Corp. · Jan 1984
PROCEDURE 460 FOR DETERM. OF CHLORIDE
K833166 · Sigma Chemical Co. · Oct 1983