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MicroScan MicroStrep Plus Panel-Tetracycline

by Dade Microscan, Inc. 510(k)

Active United States

510(k) K020939

Overview

The MicroScan MicroStrep Plus Panel-Tetracycline is a susceptibility test panel used to determine bacterial antimicrobial agent susceptibility for Streptococcus species, Enterococcus species, and other fastidious gram-positive cocci. It is designed for use with the MicroScan WalkAway System or for manual reading of results by trained laboratory personnel.

The panels are supplied in various sizes and are intended for use in clinical settings. They are not described as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device has FDA 510(k) clearance with product code LTT and was cleared on May 17, 2002.

AI-generated from registry data, 23 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 NumberK020939 Date17 May 2002ClearedStatusActive

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
LTT
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 MicroScan MicroStrep Plus Panel-Tetracycline used for?

    The MicroScan MicroStrep Plus Panel-Tetracycline is a susceptibility test panel used to determine bacterial antimicrobial agent susceptibility for Streptococcus species, Enterococcus species, and other fastidious gram-positive cocci in clinical laboratory settings.

  • How is the MicroScan MicroStrep Plus Panel-Tetracycline supplied?

    The panels are supplied in various sizes and are designed for use with the MicroScan WalkAway System or for manual reading of results by trained laboratory personnel. No specific information about single-use status or sterility is provided.

  • What is the regulatory status of the MicroScan MicroStrep Plus Panel-Tetracycline?

    The device has FDA 510(k) clearance with product code LTT and was cleared on May 17, 2002. It is classified as a Class II device and was determined to be substantially equivalent to predicate devices.

  • What systems can the MicroScan MicroStrep Plus Panel-Tetracycline be used with?

    The MicroScan MicroStrep Plus Panel-Tetracycline is designed for use with the MicroScan WalkAway System or can be manually read by trained laboratory personnel. It is not compatible with other automated systems mentioned in the device data.