FDA 510(k)

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

Numéro K : K223162 · 2023-03-17

Date de décision2023-03-17

Code produitLDJ

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT 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 2023-03-17 under 510(k) number K223162. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT?

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K223162.

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

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT received FDA 510(k) clearance on 2023-03-17, under 510(k) number K223162.

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

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, Healgen® Accurate Oral Fluid Drug Test COT?

The FDA product code for Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT is LDJ.

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Autres dossiers indiquant Healgen Scientific,, LLC en tant que demandeur

K260095Heal-Check Rapid COVID-19 Antigen Self-Test K253705Healgen® Accurate Oral Fluid Drug Test K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card K251800Healgen® URS Test Strips K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

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Source officielle

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