Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Healgen Scientific,, LLC — Predicate Candidate Screening

27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
216 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260095Heal-Check Rapid COVID-19 Antigen Self-TestHealgen Scientific,, LLC2026-04-13900
K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC2026-03-161120
K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® AccHealgen Scientific,, LLC2026-02-121850
K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen AccuratHealgen Scientific,, LLC2025-12-23360
K251800Healgen® URS Test StripsHealgen Scientific,, LLC2025-12-231940
K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)TeHealgen Scientific,, LLC2025-08-15500
K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen AcHealgen Scientific,, LLC2024-12-17490
K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); HealHealgen Scientific,, LLC2024-05-13350
K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLC2024-04-192550
K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen AccuratHealgen Scientific,, LLC2024-04-12310
K231045Healgen URS Test StripsHealgen Scientific,, LLC2023-06-16650
K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate OrHealgen Scientific,, LLC2023-03-171610
K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC2022-03-162100
K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Healgen Scientific,, LLC2017-08-022160
K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Healgen Scientific,, LLC2016-05-231590
K152269Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), HHealgen Scientific,, LLC2015-09-09290
K151348Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC2015-08-18900
K151642Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine THealgen Scientific,, LLC2015-08-13560
K150356Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Healgen Scientific,, LLC2015-05-13900
K150791Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), HHealgen Scientific,, LLC2015-04-24300
K150096Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card)Healgen Scientific,, LLC2015-03-04430
K143187Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), HHealgen Scientific,, LLC2015-01-27830
K142280Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), HealHealgen Scientific,, LLC2014-10-16620
K141647HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP Healgen Scientific,, LLC2014-07-17280
K140546HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP Healgen Scientific,, LLC2014-06-06942
K123703HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONEHealgen Scientific,, LLC2013-04-101283
K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT Healgen Scientific,, LLC2012-04-172791

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda