The following data is part of a premarket notification filed by Taiwan Unison Biotech, Inc. with the FDA for Uniscan -doa System.
| Device ID | K080347 |
| 510k Number | K080347 |
| Device Name: | UNISCAN -DOA SYSTEM |
| Classification | Thin Layer Chromatography, Methamphetamine |
| Applicant | TAIWAN UNISON BIOTECH, INC. 3F, NO. 22, KEDUNG 3RD ROAD Chunan, Miaoli, TW 350 |
| Contact | Kuang-pin Hsiung |
| Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-08 |
| Decision Date | 2008-10-09 |
| Summary: | summary |