Cleared Traditional

K922943 - NOVA NA/K/CL/LI MODULE

K922943 is the FDA 510(k) clearance for NOVA NA/K/CL/LI MODULE by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K922943 · Nova Biomedical Corp. · Chemistry device
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Oct 1992
Decision
117d
Days
Class 2
Risk

K922943 is an FDA 510(k) clearance for the NOVA NA/K/CL/LI MODULE. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on October 13, 1992 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Nova Biomedical Corp. devices

Submission Details

510(k) Number K922943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date October 13, 1992
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
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 49
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K922943.
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · Dade Behring, Inc. · Mar 2001
ALCYON 300I (WITH ISE MODULE) ANALYZER
K993083 · Abbott Laboratories · Oct 1999
EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
K961326 · Medica Corp. · Jun 1996
MILES POTASSIUM METHOD
K923038 · Heraeus Kulzer, Inc. · Aug 1992
NOVA 5 NA/K/C1 ALALYZER
K915177 · Nova Biomedical Corp. · Jan 1992
NOVA 11 NA/K/LI ANALYZER
K915178 · Nova Biomedical Corp. · Jan 1992