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Mic-Concept System

by Microtech Medical Systems, Inc.

510(k) K852613

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852613 Date20 Sep 1985ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 19 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 MIC-CONCEPT SYSTEM is a device type Susceptibility Test Cards, Antimicrobial used in Microbiology. It is designed to determine the susceptibility of microorganisms to antimicrobial agents.

The system is supplied by Microtech Medical Systems, Inc. and is classified as a Class 2 device under regulation number 866.1640. It received FDA 510(k) clearance on September 20, 1985, with the decision code SESE indicating it is substantially equivalent.

Other devices from Microtech Medical Systems, Inc.

See all devices from Microtech Medical Systems, Inc. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MIC-CONCEPT SYSTEM used for?

    The MIC-CONCEPT SYSTEM is a device used in Microbiology to determine the susceptibility of microorganisms to antimicrobial agents.

  • How is the MIC-CONCEPT SYSTEM supplied?

    The MIC-CONCEPT SYSTEM is supplied by Microtech Medical Systems, Inc. and is classified as a Class 2 device under regulation number 866.1640.

  • What is the regulatory status of the MIC-CONCEPT SYSTEM?

    The MIC-CONCEPT SYSTEM received FDA 510(k) clearance on September 20, 1985, with the decision code SESE indicating it is substantially equivalent.

  • What is the product code for the MIC-CONCEPT SYSTEM?

    The product code for the MIC-CONCEPT SYSTEM is LTW, which indicates it is a Susceptibility Test Card, Antimicrobial.