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Chloride/Carbon Dioxide Reagent Set

by Nobel Scientific Industries, Inc.

510(k) K781275

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 NumberK781275 Date31 Aug 1978ClearedStatusActive

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  • Withdrawn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
JFS
Device Class
Class II
Regulation
21 CFR Part 862.1170
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Coulometric Chloride Reagent Set, classified under 21 CFR 862.1170, designed for the quantitative determination of chloride and carbon dioxide in clinical chemistry. It employs coulometric titration principles to measure electrolyte levels in serum or plasma samples, supporting diagnostic assessments of metabolic and renal function.

The Chloride/Carbon Dioxide Reagent Set is supplied as a single-use diagnostic reagent kit for in vitro laboratory use. It is intended for use in clinical chemistry analyzers and requires compliance with 21 CFR Part 862 regulations. Authorized under FDA 510(k) clearance (K781275) as substantially equivalent to a predicate device, it is regulated under the Clinical Chemistry advisory committee (CH) and falls within Class II medical devices.

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