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FDA 510(k)

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators

K-Number: K161216 · 2017-06-14

ApplicantImmunalysis Corporation
Decision Date2017-06-14
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators is a medical device manufactured by Immunalysis Corporation. It received FDA 510(k) clearance on 2017-06-14 under approval number K161216. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators?

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators is a medical device that received FDA 510(k) clearance on 2017-06-14. It is manufactured by Immunalysis Corporation. The 510(k) number is K161216.

When was Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators approved by the FDA?

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators received FDA 510(k) clearance on 2017-06-14, under approval number K161216.

What company makes Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators?

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators is manufactured by Immunalysis Corporation.

What is the FDA product code for Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators?

The FDA product code for Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators is DJG.

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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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