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Du Pont Analyst Analytical Test Rotor:CHEM-14,Cali

by E.I. Dupont DE Nemours & Co., Inc. 510(k)

Active United States

510(k) K901017

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK901017 Date15 May 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
JFJ
Device Class
Class II
Regulation
21 CFR Part 862.1070
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Du Pont Analyst Analytical Test Rotor:Chem-14,Cali is a catalytic method device used for amylase testing, classified under the Clinical Chemistry medical specialty. It is a diagnostic test component designed to work with the Du Pont Analyst system to perform enzymatic assays for amylase activity in clinical specimens.

This device received FDA 510(k) clearance under K901017 on May 15, 1990, and is classified as a Class II medical device with product code JFJ and regulation number 862.1070. It was manufactured by E.I. Dupont DE Nemours & Co., Inc. in Wilmington, Delaware, and is intended for use in clinical laboratory settings as part of an automated analytical system.

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