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FDA 510(k)

Healgen URS Test Strips

K-Number: K231045 · 2023-06-16

ApplicantHealgen Scientific,, LLC
Decision Date2023-06-16
Product CodeLJX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Healgen URS Test Strips is a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2023-06-16 under approval number K231045. The device is classified under product code LJX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Healgen URS Test Strips?

Healgen URS Test Strips is a medical device that received FDA 510(k) clearance on 2023-06-16. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K231045.

When was Healgen URS Test Strips approved by the FDA?

Healgen URS Test Strips received FDA 510(k) clearance on 2023-06-16, under approval number K231045.

What company makes Healgen URS Test Strips?

Healgen URS Test Strips is manufactured by Healgen Scientific,, LLC.

What is the FDA product code for Healgen URS Test Strips?

The FDA product code for Healgen URS Test Strips is LJX.

Other Devices by Healgen Scientific,, LLC

K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card K212623Healgen Strep A Rapid Test Strip (Throat Swab) K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

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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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