510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253705Substantially Equivalent

Healgen® Accurate Oral Fluid Drug Test

Healgen Scientific LLC, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253705 is the FDA 510(k) clearance record for Healgen® Accurate Oral Fluid Drug Test, a class II device, cleared for Healgen Scientific,, LLC on under FDA product code DJC (Thin Layer Chromatography, Methamphetamine). FDA records list 27 510(k) clearances for Healgen Scientific,, LLC, from to . As of , FDA records show no recalls naming K253705.

Clearance record

Decision date
Received
(112 days to decision)
Product code
DJC Thin Layer Chromatography, Methamphetamine
Regulation
21 CFR 862.3610
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Healgen Scientific,, LLC 3818 Fuqua St., Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DJC

Trailing 12 months
1 clearance under product code DJC in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DJC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260