FDA 510(k)

Healgen® Accurate Oral Fluid Drug Test

N.º K: K253705 · 2026-03-16

Fecha de decisión2026-03-16

Código de productoDJC

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

Healgen® Accurate Oral Fluid Drug Test is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253705. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Healgen® Accurate Oral Fluid Drug Test?

Healgen® Accurate Oral Fluid Drug Test is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K253705.

When did Healgen® Accurate Oral Fluid Drug Test receive FDA 510(k) clearance?

Healgen® Accurate Oral Fluid Drug Test received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253705.

Who is the listed applicant for Healgen® Accurate Oral Fluid Drug Test?

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

What is the FDA product code for Healgen® Accurate Oral Fluid Drug Test?

The FDA product code for Healgen® Accurate Oral Fluid Drug Test is DJC.

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K260095Heal-Check Rapid COVID-19 Antigen Self-Test K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test K251800Healgen® URS Test Strips K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

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Fuente oficial

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