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Pasco MIC and MIC/ID Panels

by Pasco Laboratories, Inc. 30 variants

510(k) K972567

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 NumberK972567 Date20 Aug 1997ClearedStatusActive

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  • Withdrawn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
JWY
Device Class
Class II
Regulation
21 CFR Part 866.1640
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 are manual antimicrobial susceptibility test systems classified as Class II devices. They consist of frozen microtiter plates that contain two‑fold serial dilutions of antimicrobial agents for quantitative measurement of minimum inhibitory concentrations (MIC) and biochemical identification of microorganisms.

In the clinical laboratory the panels are thawed, inoculated with bacterial isolates, and incubated for 16–24 hours; results are read by visual observation of growth or color change. The product is supplied as sterile, single‑use panels and is cleared under FDA 510(k) (K972567) with product code JWY.

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