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Pasco Mic And Mic/id Panels, Erythromycin

by Pasco Laboratories, Inc. 510(k)

Active United States

510(k) K992647

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992647 Date19 Oct 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  • Withdrawn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
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.

The Pasco Mic And Mic/id Panels, Erythromycin are susceptibility test discs, antimicrobial, used in microbiology. They are classified as a class 2 device. The device is used to determine the susceptibility of microorganisms to erythromycin. The panels are part of a microbiology testing system.

The Pasco Mic And Mic/id Panels, Erythromycin are supplied with a product code of JTN and a regulation number of 866.1620. The device has been cleared with a Traditional 510K clearance. The panels are associated with registration numbers and fei numbers as listed. The device is intended for use in a microbiology setting.

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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 are the Pasco Mic And Mic/id Panels, Erythromycin used for?

    The panels are used to determine the susceptibility of microorganisms to erythromycin in a microbiology setting.

  • How are the Pasco Mic And Mic/id Panels, Erythromycin supplied?

    The panels are part of a microbiology testing system and are supplied with a product code of JTN.

  • What is the regulatory classification of the Pasco Mic And Mic/id Panels, Erythromycin?

    The device is classified as a class 2 device with a regulation number of 866.1620.

  • What type of clearance does the Pasco Mic And Mic/id Panels, Erythromycin have?

    The device has been cleared with a Traditional 510K clearance.