The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Barbiturate Urine Cassette Test.
| Device ID | K003647 |
| 510k Number | K003647 |
| Device Name: | INSTANT-VIEW BARBITURATE URINE CASSETTE TEST |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-27 |
| Decision Date | 2001-05-29 |