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Pasco MIC and MIC/ID Panels

by Pasco Laboratories, Inc. 30 variants

510(k) K982235

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 NumberK982235 Date30 Jul 1998ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

Pasco MIC and MIC/ID Panels are susceptibility test discs, antimicrobial, used for determining the minimum inhibitory concentration (MIC) of bacterial isolates. The device consists of frozen microtiter plates containing twofold dilutions of antimicrobial agents, enabling visual observation of growth or color changes after incubation.

Clinical laboratory personnel inoculate the panels with bacterial isolates and incubate them for 16-24 hours. After incubation, the device is observed for visible growth or color changes to determine MIC, and biochemical identification is determined by metabolic activity. The device is supplied in a frozen state and is intended for use in clinical microbiology laboratories.

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Questions

AI-generated answers, 23 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 Pasco MIC and MIC/ID Panel used for?

    The Pasco MIC and MIC/ID Panels are used to determine the minimum inhibitory concentration (MIC) of bacterial isolates by observing growth or color changes in frozen microtiter plates containing twofold dilutions of antimicrobial agents after incubation.

  • How is the Pasco MIC and MIC/ID Panel supplied and stored?

    The device is supplied in a frozen state and must be kept frozen until use, as it consists of frozen microtiter plates containing antimicrobial agent dilutions intended for clinical microbiology laboratory use.

  • Is the Pasco MIC and MIC/ID Panel reusable or single-use?

    The Pasco MIC and MIC/ID Panels are intended for single-use only, as they are inoculated with bacterial isolates and observed after incubation, with no indication of reuse or reprocessing in the device description.