The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Multi-drug Of Abuse Urine Test,urine Cup Test, Amphetamine Urine Test(cassette, Dip-strip), Cocaine, Methamphetamine.
| Device ID | K063545 |
| 510k Number | K063545 |
| Device Name: | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Contact | Daiting Rong |
| Correspondent | Daiting Rong ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| Subsequent Product Code | NFV |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-24 |
| Decision Date | 2007-05-07 |
| Summary: | summary |