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Pasco Mic And Mic/Id Panels

by Pasco Laboratories, Inc. 510(k)

Active United States

510(k) K971951

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971951 Date15 Aug 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Overview

AI-generated summary, 28 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 Pasco Mic And Mic/Id Panels are manual antimicrobial susceptibility test systems used to determine the susceptibility of bacterial pathogens to antimicrobial agents and to perform biochemical identification. They consist of frozen microtiter plates containing twofold dilutions of antimicrobial agents. The device detects minimum inhibitory concentration via visual observation of growth or color changes.

The Pasco Mic And Mic/Id Panels are supplied as in vitro diagnostic devices for use in clinical laboratories. They are used by clinical laboratory personnel who inoculate panels with bacterial isolates and incubate for 16-24 hours. The device has received FDA 510(k) authorization and is classified as a class 2 device with the product code JWY.

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Questions

AI-generated answers, 28 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 Panels used for?

    The Pasco Mic And Mic/Id Panels are used to determine the susceptibility of bacterial pathogens to antimicrobial agents and to perform biochemical identification in clinical laboratories.

  • How are the Pasco Mic And Mic/Id Panels supplied?

    The Pasco Mic And Mic/Id Panels are supplied as frozen microtiter plates containing twofold dilutions of antimicrobial agents for use in clinical laboratories.

  • What is the regulatory status of the Pasco Mic And Mic/Id Panels?

    The Pasco Mic And Mic/Id Panels have received FDA 510(k) authorization and are classified as a class 2 device with the product code JWY.