Cleared Traditional

K800586 - NSI CARBON DIOXIDE REAGENT KIT

K800586 is the FDA 510(k) clearance for NSI CARBON DIOXIDE REAGENT KIT by Nobel Scientific Industries, Inc.. It is a Class 2 Chemistry device (product code JFL) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K800586 · Nobel Scientific Industries, Inc. · Chemistry device
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Apr 1980
Decision
18d
Days
Class 2
Risk

K800586 is an FDA 510(k) clearance for the NSI CARBON DIOXIDE REAGENT KIT. Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by Nobel Scientific Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1980 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 Nobel Scientific Industries, Inc. devices

Submission Details

510(k) Number K800586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date April 04, 1980
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFL Ph Rate Measurement, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - JFL Ph Rate Measurement, Carbon-dioxide

All 22
Devices cleared under the same product code (JFL) and FDA review panel - the closest regulatory comparables to K800586.
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656 · Shaban Mfg. Co. · Aug 1984
LIQUIZYME CO2REAGENT SET
K820388 · American Research Products Co. · Mar 1982
BAKER DIAG. ULTRARATE CO2 REAGENT KIT
K802035 · J.T. Baker Chemical Co. · Sep 1980
CARBON DIOXIDE CUP REAGENT & REF.RGT.
K800218 · Fisher Scientific Co., LLC · Feb 1980
NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE
K792254 · Nova Biomedical Corp. · Dec 1979
CO2 CUP REAGENT
K791686 · Hi Chem, Inc. · Sep 1979