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Klinar Reagent Pak #36010

by Hi Chem, Inc.

510(k) K801892

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 NumberK801892 Date23 Oct 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  • Withdrawn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
JGT
Device Class
Class II
Regulation
21 CFR Part 862.1665
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

The Klinar Reagent Pak #36010 is a reagent kit designed for flame photometry, specifically for the quantitative measurement of sodium levels in clinical chemistry. As classified under product code JGT and regulation 862.1665, this device falls under the category of Flame Photometry, Sodium, and is intended for use in laboratory settings to facilitate accurate sodium ion analysis in patient samples. Its design aligns with the requirements for Class II medical devices under special controls, ensuring compliance with regulatory standards for diagnostic accuracy and safety.

This reagent kit is supplied as a single-use disposable and is intended for use in clinical chemistry laboratories equipped for flame photometry. The device requires no special storage conditions beyond standard laboratory practices, though it must remain protected from contamination and extreme temperatures. Authorized for use in the United States following FDA clearance under 510(k) number K801892, the Klinar Reagent Pak #36010 was granted a Substantially Equivalent (SESE) decision in 1980. Its regulatory classification and approval ensure adherence to established safety and performance benchmarks for diagnostic reagents.

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