Cleared Traditional

K802155 - REAGENTS SERUM SODIUM USING THE TECH.

K802155 is the FDA 510(k) clearance for REAGENTS SERUM SODIUM USING THE TECH. by Panmed, Inc.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K802155 · Panmed, Inc. · Chemistry device
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Oct 1980
Decision
32d
Days
Class 2
Risk

K802155 is an FDA 510(k) clearance for the REAGENTS SERUM SODIUM USING THE TECH.. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Panmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 32 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 Panmed, Inc. devices

Submission Details

510(k) Number K802155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1980
Decision Date October 10, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 116
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K802155.
IL 501, NA/K ANALYZER
K812762 · Instrumentation Laboratory CO · Oct 1981
902 NA/K
K811896 · Corning Medical & Scientific · Jul 1981
NOVA 5
K811289 · Nova Biomedical Corp. · May 1981
BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.
K801795 · J.T. Baker Chemical Co. · Sep 1980
NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON
K801882 · Nova Biomedical Corp. · Sep 1980
BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM
K801896 · Beckman Instruments, Inc. · Sep 1980