Cleared Traditional

K923806 - ANALYZER: NOVA 10 CRT ANALYZER & QUALI ...

K923806 is the FDA 510(k) clearance for ANALYZER: NOVA 10 CRT ANALYZER & QUALI ... by Nova Biomedical Corp.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K923806 · Nova Biomedical Corp. · Chemistry device
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Sep 1992
Decision
62d
Days
Class 2
Risk

K923806 is an FDA 510(k) clearance for the ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER. 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 September 29, 1992 after a review of 62 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 Nova Biomedical Corp. devices

Submission Details

510(k) Number K923806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1992
Decision Date September 29, 1992
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 99
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K923806.
CIBA CORNING 300 SERIES SYSTEM
K933373 · Ciba Corning Diagnostics Corp. · Aug 1993
NOVA 8 CRT ANALYZER
K924547 · Nova Biomedical Corp. · Jan 1993
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
K924471 · Eastman Kodak Company · Nov 1992
NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION
K921937 · Nova Biomedical Corp. · Jul 1992
OLYMPUS ISE MODULE
K921718 · Olympus Corp. · Jul 1992
NOVA 14 NA/K/CL/GLU/BUN ANALYZER
K922215 · Nova Biomedical Corp. · Jul 1992