Skip to content

Avl Model 985 Electrolyte Analyzer

by Avl Scientific Corp. 510(k)

Active United States

510(k) K870657

Overview

The Avl Model 985 Electrolyte Analyzer is a clinical chemistry device designed to measure ion-specific electrolytes. It functions as an electrode system to provide analytical data for clinical diagnostic purposes.

This device has received FDA 510(k) clearance under the regulation number 862.1600. It is categorized under the clinical chemistry medical specialty and is identified by the product code CEM.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870657 Date12 May 1987ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CEM
Device Class
Class II
Regulation
21 CFR Part 862.1600
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Avl Scientific Corp.

See all devices from Avl Scientific Corp. →

Questions

  • What is the primary function of the Avl Model 985 Electrolyte Analyzer?

    This device is a clinical chemistry instrument designed to measure ion-specific electrolytes. It utilizes an electrode system to provide analytical data for clinical diagnostic purposes.

  • What is the regulatory status of this device?

    The Avl Model 985 Electrolyte Analyzer has received FDA 510(k) clearance. It is classified under regulation number 862.1600 within the clinical chemistry medical specialty.

  • How is this device categorized for regulatory purposes?

    The device is identified by the product code CEM and falls under the clinical chemistry medical specialty. It is classified as a Class 2 device, which refers to the regulatory framework used for filing and oversight.