Cleared Traditional

K832070 - AMRESCO NA/K REAGENT SET

K832070 is the FDA 510(k) clearance for AMRESCO NA/K REAGENT SET by American Research Products Co.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K832070 · American Research Products Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
46d
Days
Class 2
Risk

K832070 is an FDA 510(k) clearance for the AMRESCO NA/K REAGENT SET. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by American Research Products Co. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 K832070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1983
Decision Date August 12, 1983
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 115
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K832070.
FLOW-PAC SODIUM REAGENT SET
K833036 · American Research Products Co. · Nov 1983
STARLYTE
K832744 · Electro-Nucleonics Laboratories, Inc. · Nov 1983
DEPROTEINIZING & CLEANING SOLUTION
K832415 · Shaban Mfg. Co. · Sep 1983
POTASSIUM ANALYZER-SODIUM/ELECTROLYTE
K830588 · Shaban Mfg. Co. · Apr 1983
ELECTROLYTE STANDARD - CORNING NALK ISE
K830589 · Shaban Mfg. Co. · Apr 1983
BECKMAN ASTRA
K822039 · Beckman Instruments, Inc. · Oct 1982