The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Cocaine (benzylecgonine) Urine Cassette Test.
| Device ID | K994398 |
| 510k Number | K994398 |
| Device Name: | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-28 |
| Decision Date | 2000-07-27 |
| Summary: | summary |