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FDA 510(k)

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test

K-Number: K243064 · 2024-11-20

ApplicantEterbio, Inc.
Decision Date2024-11-20
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test is the device name listed in this FDA 510(k) record. The listed applicant is Eterbio, Inc.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K243064. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test?

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Eterbio, Inc.. The 510(k) number is K243064.

When did ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test receive FDA 510(k) clearance?

ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test received FDA 510(k) clearance on 2024-11-20, under 510(k) number K243064.

Who is the listed applicant for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test?

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

What is the FDA product code for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test?

The FDA product code for ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test is NGL.

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Related Devices (Code: NGL)

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

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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