The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Amphetamine Urine Dip Strip Test.
| Device ID | K994399 |
| 510k Number | K994399 |
| Device Name: | INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M San Diego, CA 92121 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M San Diego, CA 92121 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-28 |
| Decision Date | 2000-08-04 |
| Summary: | summary |