Cleared Traditional

K924547 - NOVA 8 CRT ANALYZER

K924547 is an FDA 510(k) clearance for NOVA 8 CRT ANALYZER, manufactured by Nova Biomedical Corp.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K924547 · Nova Biomedical Corp. · Chemistry device
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Jan 1993
Decision
141d
Days
Class 2
Risk

K924547 is an FDA 510(k) clearance for the NOVA 8 CRT ANALYZER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 141 days - within the typical 510(k) review window.

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: 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

FDA 510(k) Submission Details - K924547

510(k) Number K924547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1992
Decision Date January 28, 1993
Days to Decision 141 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
53d slower than avg
Panel avg: 88d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGS Device Classification - Class 2, Special Controls

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 133
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K924547.
CIBA CORNING 300 SERIES SYSTEM
K933373 · Ciba Corning Diagnostics Corp. · Aug 1993
HI CHEM ELECTROLYTE BUFFER
K925612 · Hichem Diagnostics · Apr 1993
HI CHEM ELECTROLYTE REFERENCE REAGENT
K925611 · Hichem Diagnostics · Feb 1993
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
K924471 · Eastman Kodak Company · Nov 1992
ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER
K923806 · Nova Biomedical Corp. · Sep 1992
NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION
K921937 · Nova Biomedical Corp. · Jul 1992