The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Multi-drug Of Abuse Urine Test (cup, Panel Cassette).
| Device ID | K131645 |
| 510k Number | K131645 |
| Device Name: | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-05 |
| Decision Date | 2013-10-07 |
| Summary: | summary |