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 Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)
Healgen Scientific,, LLC · Clinical Toxicology
Open FDA's page for this record- Third party flag
- N
- City
- Houston
- Advisory committee description
- Clinical Toxicology
- Address 1
- 3818 Fuqua St.
- Statement or summary
- Summary
- Product code
- NGL
- Zip code
- 77047
- Applicant
- Healgen Scientific,, LLC
- Decision date
- 2024-05-13
- Decision code
- SESE
- Country code
- US
- Advisory committee
- TX
- Contact
- Bryan Fang
- K number
- K240949
- State
- TX
- Date received
- 2024-04-08
- Review advisory committee
- TX
- Postal code
- 77047
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
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 Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)
- Harmonized identifiers (openFDA)
- Device name
- Test, Opiates, Over The Counter
- Medical specialty description
- Clinical Toxicology
- Regulation number
- 862.3650
- Device class
- 2
- Registration number
- 3008054239, 2087033, 3008517993, 1417592, 3005360469, 3043127647, 2060833, 3031823359, 3021986677, 3009212837, 3013077867, 3006305917, 3006048451, 3030648160, 3016447251, 3009414546, 3017060097, 3004635103, 3031697086, 3030413233, 3016609999, 3017904598, 3024753119, 3025041446, 3038560224, 1910144, 3005641941, 3036649420, 3013223546, 1649661, 3038614708, 3027519599, 3032147516, 3005984081, 3043196750, 3010220539, 3010852191, 3009238284, 3030897502, 3014223276 +22 more
- FEI number
- 3008054239, 3008517993, 1417592, 3043127647, 3003102569, 3031823359, 3021986677, 3009212837, 3013077867, 3006305917, 3006048451, 3030648160, 1000306617, 3016447251, 3009414546, 3017060097, 3004635103, 3031697086, 3030413233, 3016609999, 3017904598, 3024753119, 3025041446, 3038560224, 1910144, 3005641941, 3036649420, 3013223546, 3001452245, 3038614708, 3027519599, 3032147516, 3005984081, 3000210620, 3043196750, 3010220539, 3010852191, 3009238284, 3030897502, 3014223276 +22 more