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Sceptor Enteric Mic Panel

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K854102

Overview

The Sceptor Enteric Mic Panel is a Manual Antimicrobial Susceptibility Test System, classified as a Class 2 device in the field of Microbiology. It is designed to provide antimicrobial susceptibility testing. The device is used in microbiology laboratories to determine the effectiveness of various antimicrobial agents against specific microorganisms.

The Sceptor Enteric Mic Panel is supplied as a single unit and is intended for use in a laboratory setting. The device has been cleared through the Traditional 510(k) pathway and has been assigned the product code JWY. It is regulated by the FDA and has been assigned the regulation number 866.1640. The device is available in a single configuration, as described in the FDA clearance K854102.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854102 Date14 Nov 1985ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JWY
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Sceptor Enteric Mic Panel used for?

    The Sceptor Enteric Mic Panel is used to determine the effectiveness of various antimicrobial agents against specific microorganisms in microbiology laboratories.

  • How is the Sceptor Enteric Mic Panel supplied?

    The Sceptor Enteric Mic Panel is supplied as a single unit and is intended for use in a laboratory setting.

  • What is the regulatory classification of the Sceptor Enteric Mic Panel?

    The Sceptor Enteric Mic Panel is classified as a Class 2 device and has been cleared through the Traditional 510(k) pathway with the product code JWY and regulation number 866.1640.