The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Multi-drug Urine Test Cup (home Use), Instant-view Multi-drug Urine Test Panel (home Use).
| Device ID | K152122 |
| 510k Number | K152122 |
| Device Name: | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Contact | Michael Chang-chien |
| Correspondent | Jimmy Jing 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-30 |
| Decision Date | 2016-06-24 |
| Summary: | summary |