The following data is part of a premarket notification filed by Applied Technology Ventures, L.l.c. with the FDA for Genie Cup Integrated Screening Device.
| Device ID | K980836 |
| 510k Number | K980836 |
| Device Name: | GENIE CUP INTEGRATED SCREENING DEVICE |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | APPLIED TECHNOLOGY VENTURES, L.L.C. 6 TAFT CT., SUITE 150 Rockville, MD 20850 |
| Contact | Richard Roblin |
| Correspondent | Richard Roblin APPLIED TECHNOLOGY VENTURES, L.L.C. 6 TAFT CT., SUITE 150 Rockville, MD 20850 |
| Product Code | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-04 |
| Decision Date | 1998-06-29 |