The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Milti-drug Of Abuse Urine Test (panel, Cup), Instant-verdict Multi-drug Of Abuse Urine Test (panel, Cup).
| Device ID | K100051 |
| 510k Number | K100051 |
| Device Name: | INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Contact | Nasishu Wang |
| Correspondent | Nasishu Wang ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-08 |
| Decision Date | 2010-07-06 |
| Summary: | summary |