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FDA 510(k)

Remel Spectra ESBL

K-Number: K162620 · 2017-05-01

ApplicantRemel, Inc.
Decision Date2017-05-01
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Remel Spectra ESBL is a medical device manufactured by Remel, Inc.. It received FDA 510(k) clearance on 2017-05-01 under approval 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. It is manufactured by Remel, Inc.. The 510(k) number is K162620.

When was Remel Spectra ESBL approved by the FDA?

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

What company makes Remel Spectra ESBL?

Remel Spectra ESBL is manufactured by Remel, Inc..

What is the FDA product code for Remel Spectra ESBL?

The FDA product code for Remel Spectra ESBL is JSO.

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Official Source

View on FDA Database →

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

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