Cleared Traditional

K851350 - ION 2 REAGENT KI

K851350 is the FDA 510(k) clearance for ION 2 REAGENT KI by Hi Chem, Inc.. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K851350 · Hi Chem, Inc. · Chemistry device
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Apr 1985
Decision
25d
Days
Class 2
Risk

K851350 is an FDA 510(k) clearance for the ION 2 REAGENT KI. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Hi Chem, Inc. devices

Submission Details

510(k) Number K851350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1985
Decision Date April 29, 1985
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEM Electrode, Ion Specific, Potassium

All 52
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K851350.
IRON
K854298 · Boehringer Mannheim Corp. · Nov 1985
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
K853531 · American Dade · Sep 1985
VISION POTASSIUM
K850950 · Abbott Laboratories · Aug 1985
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
K844955 · Miles Laboratories, Inc. · Mar 1985
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
K844044 · Medica Corp. · Nov 1984
DACOS PLUS LYTES OPTION
K843239 · Coulter Electronics, Inc. · Oct 1984