Healgen Scientific, LLC - FDA 510(k) Cleared Devices
26
Total
26
Cleared
0
Denied
FDA 510(k) cleared devices by Healgen Scientific, LLC Chemistry ✕
10 devices
Cleared
Dec 23, 2025
Healgen® URS Test Strips
Chemistry
194d
Cleared
Jun 16, 2023
Healgen URS Test Strips
Chemistry
65d
Cleared
Aug 13, 2015
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Chemistry
56d
Cleared
May 13, 2015
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Chemistry
90d
Cleared
Jan 27, 2015
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone...
Chemistry
83d
Cleared
Oct 16, 2014
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test...
Chemistry
62d
Cleared
Jul 17, 2014
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP,...
Chemistry
28d
Cleared
Jun 06, 2014
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
Chemistry
94d
Cleared
Apr 10, 2013
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY...
Chemistry
128d
Cleared
Apr 17, 2012
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR...
Chemistry
279d