Cleared Traditional

K830588 - POTASSIUM ANALYZER-SODIUM/ELECTROLYTE

K830588 is the FDA 510(k) clearance for POTASSIUM ANALYZER-SODIUM/ELECTROLYTE by Shaban Mfg. Co.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K830588 · Shaban Mfg. Co. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1983
Decision
63d
Days
Class 2
Risk

K830588 is an FDA 510(k) clearance for the POTASSIUM ANALYZER-SODIUM/ELECTROLYTE. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Shaban Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1983 after a review of 63 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 Shaban Mfg. Co. devices

Submission Details

510(k) Number K830588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date April 27, 1983
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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 K830588.
STARLYTE
K832744 · Electro-Nucleonics Laboratories, Inc. · Nov 1983
DEPROTEINIZING & CLEANING SOLUTION
K832415 · Shaban Mfg. Co. · Sep 1983
AMRESCO NA/K REAGENT SET
K832070 · American Research Products Co. · Aug 1983
ELECTROLYTE STANDARD - CORNING NALK ISE
K830589 · Shaban Mfg. Co. · Apr 1983
BECKMAN ASTRA
K822039 · Beckman Instruments, Inc. · Oct 1982
LIQUIZYME NA+/K+ REAGENT SET
K820395 · American Research Products Co. · Mar 1982