Cleared Traditional

K844955 - SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &

K844955 is an FDA 510(k) clearance for SERALYZER POTASSIUM REAGENT STRIPS, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K844955 · Miles Laboratories, Inc. · Chemistry device
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Mar 1985
Decision
88d
Days
Class 2
Risk

K844955 is an FDA 510(k) clearance for the SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on March 19, 1985 after a review of 88 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.

FDA 510(k) Submission Details - K844955

510(k) Number K844955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1984
Decision Date March 19, 1985
Days to Decision 88 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
1d faster than avg
Panel avg: 89d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEM Device Classification - Class 2, Special Controls

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 88
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K844955.
CHEM PRO 1000 CHEMISTRY ANALYSIS
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ELECTROLYTE ANALYZER
K851808 · Ionetics, Inc. · Jun 1985
ION 2 REAGENT KI
K851350 · Hi Chem, Inc. · Apr 1985
MODIFY ELECTROLYTE ANALYZER MODEL SERA-210
K844806 · Horiba Instruments, Inc. · Jan 1985
ULTRA LYTE POTASSIUM REAGENT KIT
K843454 · Ultra Quest Diagnostics, Inc. · Nov 1984
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
K844044 · Medica Corp. · Nov 1984
K844955 · SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
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