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FDA 510(k)

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)

K-Number: K240295 · 2024-03-28

ApplicantInstanosis, Inc.
Decision Date2024-03-28
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) is a medical device manufactured by Instanosis, Inc.. It received FDA 510(k) clearance on 2024-03-28 under approval number K240295. 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 InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)?

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) is a medical device that received FDA 510(k) clearance on 2024-03-28. It is manufactured by Instanosis, Inc.. The 510(k) number is K240295.

When was InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) approved by the FDA?

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) received FDA 510(k) clearance on 2024-03-28, under approval number K240295.

What company makes InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)?

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) is manufactured by Instanosis, Inc..

What is the FDA product code for InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)?

The FDA product code for InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) is NGL.

Related Clinical Trials

NCT05333679 Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) COMPLETED NCT03065335 Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder RECRUITING

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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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