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NSI Carbon Dioxide Reagent Kit

by Nobel Scientific Industries, Inc.

510(k) K800586

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800586 Date4 Apr 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JFL
Device Class
Class II
Regulation
21 CFR Part 862.1160
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Bicarbonate/Carbon Dioxide Test System, classified under product code JFL (Ph Rate Measurement, Carbon-Dioxide). It is designed to measure bicarbonate and carbon dioxide levels in plasma, serum, and whole blood, aiding in the diagnosis and management of acid-base balance disorders.

The NSI Carbon Dioxide Reagent Kit is intended for use in clinical chemistry laboratories. Supplied as a single-use reagent kit, it requires FDA 510(k) clearance (K800586) and falls under Class II regulatory classification. Storage and handling conditions are not specified in the data, but it is intended for professional medical use in accredited diagnostic settings.

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