Cleared Traditional

K842873 - STANDARDS & ACCESSORIES FOR NOVA INSTRU

K842873 is an FDA 510(k) clearance for STANDARDS & ACCESSORIES FOR NOVA INSTRU, manufactured by Diagnostic Chemicals, Ltd. (Usa). The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K842873 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Oct 1984
Decision
74d
Days
Class 2
Risk

K842873 is an FDA 510(k) clearance for the STANDARDS & ACCESSORIES FOR NOVA INSTRU. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Walker, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 74 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 Diagnostic Chemicals, Ltd. (Usa) devices

FDA 510(k) Submission Details - K842873

510(k) Number K842873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date October 05, 1984
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
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 134
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K842873.
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