The following data is part of a premarket notification filed by Healgen Scientific, Llc with the FDA for Healgen Coc One Step Cocaine Test Strip:morhpine Test Strip (cassette, Cup, Dip Card).
| Device ID | K141647 |
| 510k Number | K141647 |
| Device Name: | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | HEALGEN SCIENTIFIC, LLC 504 EAST DIAMNOND AVE. SUITE F Gaithersburg, MD 20877 |
| Contact | Joe Shia |
| Correspondent | Joe Shia HEALGEN SCIENTIFIC, LLC 504 EAST DIAMNOND AVE. SUITE F Gaithersburg, MD 20877 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-19 |
| Decision Date | 2014-07-17 |
| Summary: | summary |