Flame Photometer Molel 4600, Kda

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

510(k) Number

K770824 ↗

FDA Product Code

JIH

Device Class

Class II

Regulation

21 CFR Part 862.3560

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical use of the Flame Photometer Molel 4600, Kda?

  This device is specifically intended for flame photometry, which is a method used to measure chemical concentrations. It is categorized as a clinical toxicology instrument designed for the measurement of lithium.

• What is the regulatory status of this flame photometer?

  The device is classified as an FDA class 2 medical device under 21 CFR 862.3560. It received FDA 510(k) clearance on July 15, 1977, under the traditional clearance type.

• Which medical specialty does this instrument support?

  The Flame Photometer Molel 4600, Kda is utilized within the field of clinical toxicology. It is designed to assist in the analysis of chemical concentrations, specifically lithium, to support clinical diagnostic processes.