FDA 510(k)

Remel Spectra ESBL

K-Number: K162620 · 2017-05-01

Decision Date2017-05-01

Product CodeJSO

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Remel Spectra ESBL is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K162620. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Remel Spectra ESBL?

Remel Spectra ESBL is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Remel, Inc.. The 510(k) number is K162620.

When did Remel Spectra ESBL receive FDA 510(k) clearance?

Remel Spectra ESBL received FDA 510(k) clearance on 2017-05-01, under 510(k) number K162620.

Who is the listed applicant for Remel Spectra ESBL?

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

What is the FDA product code for Remel Spectra ESBL?

The FDA product code for Remel Spectra ESBL is JSO.

Related Devices (Code: JSO)

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.

K190553HardyCHROM CREHardy Diagnostics K181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-Rad K160512HardyCHROM ESBLHardy Diagnostics K162076chromID MRSAbioMerieux, Inc.K151688chromID MRSAbioMerieux, Inc.

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.