FDA 510(k)

PanNAT STEC Test

K-Number: K173330 · 2018-06-01

Decision Date2018-06-01

Product CodePCI

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

PanNAT STEC Test is the device name listed in this FDA 510(k) record. The listed applicant is Micronics, Inc.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K173330. The device is classified under product code PCI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PanNAT STEC Test?

PanNAT STEC Test is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Micronics, Inc.. The 510(k) number is K173330.

When did PanNAT STEC Test receive FDA 510(k) clearance?

PanNAT STEC Test received FDA 510(k) clearance on 2018-06-01, under 510(k) number K173330.

Who is the listed applicant for PanNAT STEC Test?

The FDA 510(k) record lists Micronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PanNAT STEC Test?

The FDA product code for PanNAT STEC Test is PCI.

Related Devices (Code: PCI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.