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PanNAT STEC Test

by Micronics, Inc.

510(k) K173330

PanNAT STEC Test is a medical device (FDA Class II; FDA product code PCI, Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System) made by Micronics, Inc., cleared under FDA 510(k) K173330 on 1 Jun 2018, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173330 Date1 Jun 2018ClearedStatusActive

Official records

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  • Withdrawn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
PCI
Device class
Class II
Regulation
21 CFR Part 866.3990
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code PCI (Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System).

Other devices from Micronics, Inc.