FDA 510(k) Applications Submitted by HEALGEN SCIENTIFIC LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240949 |
04/08/2024 |
Healgen« Accurate Fentanyl Rapid Test Cassette (Urine); Healgen« Accurate Rapid Fentanyl Test Cassette (Urine); Healgen« Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen« Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen« Accurate Fentanyl Rapi |
Healgen Scientific LLC |
| K150096 |
01/20/2015 |
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
| K150356 |
02/12/2015 |
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card |
HEALGEN SCIENTIFIC LLC |
| K240686 |
03/12/2024 |
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card |
Healgen Scientific LLC |
| K150791 |
03/25/2015 |
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
| K231045 |
04/12/2023 |
Healgen URS Test Strips |
Healgen Scientific LLC |
| K151348 |
05/20/2015 |
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
| K151642 |
06/18/2015 |
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card |
HEALGEN SCIENTIFIC LLC |
| K152269 |
08/11/2015 |
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
| K142280 |
08/15/2014 |
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
| K223162 |
10/07/2022 |
Healgen« Accurate Oral Fluid Drug Test, Healgen« Accurate Oral Fluid Drug Test COT |
Healgen Scientific LLC |
| K243365 |
10/29/2024 |
Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup |
Healgen Scientific LLC |
| K143187 |
11/05/2014 |
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) |
Healgen Scientific LLC |
| K153597 |
12/16/2015 |
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card |
HEALGEN SCIENTIFIC LLC |
| K163704 |
12/29/2016 |
Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card |
HEALGEN SCIENTIFIC LLC |
| K232377 |
08/08/2023 |
Healgen Rapid COVID-19 Antigen Test |
Healgen Scientific LLC |
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