Healgen® Accurate Oral Fluid Drug Test
K-Number: K253705 · 2026-03-16
Device Summary
Frequently Asked Questions
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.
Other records listing Healgen Scientific,, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: DJC)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.