The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc with the FDA for Instant-view Plus Multi-drug Of Abuse Urine Test - Simple Cup (otc Use), Instant-view Plus Multi-drug Urine Test - Simple Cup (prescription Use).
| Device ID | K173303 |
| 510k Number | K173303 |
| Device Name: | INSTANT-VIEW Plus Multi-Drug Of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW Plus Multi-Drug Urine Test - Simple Cup (Prescription Use) |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Alfa Scientific Designs, Inc 13200 Gregg Street Poway, CA 92064 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang Alfa Scientific Designs, Inc 13200 Gregg Street 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 | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| Subsequent Product Code | NFT |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| Subsequent Product Code | NGI |
| Subsequent Product Code | NGL |
| Subsequent Product Code | NGM |
| Subsequent Product Code | PTG |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-18 |
| Decision Date | 2018-02-23 |
| Summary: | summary |