The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Bup/nbup Urine Test. Instant-verdict Bup/nbup Urine Test; Instant-confirmatory Bup/nbup Urine Test.
| Device ID | K060527 |
| 510k Number | K060527 |
| Device Name: | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-28 |
| Decision Date | 2006-07-25 |
| Summary: | summary |