|
|
| Document Number | K240949 |
| Test Name | Shanghai Douglas Medical Device Co., Ltd., Accubio Accurate Fentanyl Rapid Test Dip Card (Urine) |
| Manufacturer Name | Healgen Scientific,, LLC |
| Consumer Information Phone Number | (866)982-3818 |
| Test Type | Fentanyl |
| Effective Date | 08/09/2024 |
| |
| Device Classification Name |
Test, Opiates, Over The Counter
|
|---|
| 510(k) Number |
K240949 |
|---|
| 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) |
|---|
| Applicant |
| Healgen Scientific,, LLC |
| 3818 Fuqua St. |
|
Houston,
TX
77047
|
|
| Applicant Contact |
Bryan Fang |
| Correspondent |
| LSI International, Inc. |
| 504 E Diamond Ave. |
| Suite H |
|
Gaithersburg,
MD
20877
|
|
| Correspondent Contact |
Joe Shia |
| Regulation Number | 862.3650 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/08/2024 |
|---|
| Decision Date | 05/13/2024 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Toxicology
|
|---|
| 510k Review Panel |
Toxicology
|
|---|
| Summary |
Summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
|
