The following data is part of a premarket notification filed by Healgen Scientific, Llc with the FDA for Healgen Thc One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test.
| Device ID | K140546 |
| 510k Number | K140546 |
| Device Name: | HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | HEALGEN SCIENTIFIC, LLC 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20877 |
| Contact | Joe Shia |
| Correspondent | Joe Shia HEALGEN SCIENTIFIC, LLC 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20877 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00639277288929 | K140546 | 000 |
| 00049696726030 | K140546 | 000 |
| 00004969673664 | K140546 | 000 |
| 00049696736664 | K140546 | 000 |