HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
FDA 510(k) clearance K140546 · decided 2014-06-06
Clearance details
- K-number
- K140546
- Device name
- HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
- Applicant
- Healgen Scientific,, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-03-04
- Decision date
- 2014-06-06
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- LDJ
- Device class
- 2
- Regulation number
- 862.3870
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Gaithersburg, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AT HOME MARIJUANA TEST STRIP, SKU 900752 recall (Z-0262-2024) | Family Dollar Stores, Llc. | 2023-11-07 |
| AT HOME MARIJUANA TEST STRIP, SKU 900752 recall (Z-1542-2022) | Family Dollar Stores, Llc. | 2022-08-17 |