The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Benzodiazepine (bzd) Urine Test (dip Strip).
| Device ID | K003879 |
| 510k Number | K003879 |
| Device Name: | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Contact | Naiishu Wang |
| Correspondent | Naiishu Wang ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-15 |
| Decision Date | 2001-05-29 |