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Parallel Flame Photometer & Sodium

by American Monitor Corp.

510(k) K834248

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 NumberK834248 Date30 Jan 1984ClearedStatusActive

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  • Withdrawn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, 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.

The Parallel Flame Photometer & Sodium is a flame photometry device used for quantifying sodium concentrations in clinical chemistry. It operates by measuring the emission of light from excited sodium ions in a flame, enabling precise analytical assessments of serum or plasma samples.

This device is supplied as a reusable instrument and is classified under FDA Product Code JGT for flame photometry applications. It was granted a Traditional 510(k) clearance by the FDA in 1984 under the Clinical Chemistry advisory committee, with no third-party review. The device is intended for use in clinical laboratory settings and adheres to regulatory standards for Class II medical devices.

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