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Modification of Pasco MIC and MIC/ID Panels

by Pasco Laboratories, Inc.

510(k) K992420

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 NumberK992420 Date27 Sep 1999ClearedStatusActive

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  • Withdrawn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
JTN
Device Class
Class II
Regulation
21 CFR Part 866.1620
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 Modification of Pasco MIC and MIC/ID Panels is a device used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to antimicrobial agents and determining the biochemical identification of those organisms. The Breakpoint/ID panel provides qualitative measurement or category results.

These panels consist of frozen panels containing two-fold dilutions of antimicrobial agents and are supplied as antimicrobial susceptibility test powders packaged in vials. The device is intended for use in clinical laboratories for in vitro susceptibility testing of bacterial pathogens to therapeutic agents. The device is FDA 510K cleared with product code JTN and device class 2.

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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 purpose of the Modification of Pasco MIC and MIC/ID Panels?

    The device is used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to antimicrobial agents and determining the biochemical identification of those organisms.

  • How are the Pasco MIC and MIC/ID Panels supplied?

    These panels consist of frozen panels containing two-fold dilutions of antimicrobial agents and are supplied as antimicrobial susceptibility test powders packaged in vials.

  • What is the intended use environment for this device?

    The device is intended for use in clinical laboratories for in vitro susceptibility testing of bacterial pathogens to therapeutic agents.

  • What is the regulatory status of the Modification of Pasco MIC and MIC/ID Panels?

    The device is FDA 510K cleared with product code JTN and device class 2.