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Modification to Pasco MIC and MIC/ID Panels (Clindamycin)

by Pasco Laboratories, Inc. 510(k)

Active United States

510(k) K992143

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992143 Date16 Sep 1999ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

This device is a Manual Antimicrobial Susceptibility Test System, specifically a modification to the Pasco MIC and MIC/ID panels for clindamycin susceptibility testing. It consists of frozen panels containing two-fold dilutions of antimicrobial agents used to determine the Minimum Inhibitory Concentration (MIC) and perform biochemical identification of microorganisms.

Clinical laboratory personnel inoculate the panels with test organisms and incubate them for 16-24 hours to detect visible growth or color changes. The device is supplied as a frozen panel system for use in clinical microbiology laboratories and received FDA 510(k) clearance under K992143 on September 16, 1999, as substantially equivalent to a legally marketed device.

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Questions

AI-generated answers, 24 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 Modification to Pasco MIC and MIC/ID Panels (Clindamycin) used for?

    This device is used to determine the Minimum Inhibitory Concentration Concentration (MIC) of clindamycin and perform biochemical identification of microorganisms by detecting visible growth or color changes after inoculation and incubation of frozen panels containing two-fold dilutions of antimicrobial agents.

  • How is the Modification to Pasco MIC and MIC/ID Panels (Clindamycin) supplied and stored?

    The device is supplied as a frozen panel system intended for use in clinical microbiology laboratories, requiring frozen storage to maintain stability of the antimicrobial agents until use.

  • Is the Modification to Pasco MIC and MIC/ID Panels (Clindamycin) a single-use or reusable device?

    The device is intended for single-use per test, as each frozen panel is inoculated with a test organism and incubated for 16-24 hours to assess susceptibility and identification, after which it is discarded.

  • What regulatory clearance does the Modification to Pasco MIC and MIC/ID Panels (Clindamycin) have?

    The device received FDA 510(k) clearance under K992143 on September 16, 1999, as substantially equivalent to a legally marketed device, based on its traditional submission pathway.