The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit).
| Device ID | K020368 |
| 510k Number | K020368 |
| Device Name: | OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Lin-Zhi International, Inc. 2391 ZANKER RD., SUITE 340 San Jose, CA 95131 -1124 |
| Contact | Chiu Chin Chang |
| Correspondent | Chiu Chin Chang Lin-Zhi International, Inc. 2391 ZANKER RD., SUITE 340 San Jose, CA 95131 -1124 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-04 |
| Decision Date | 2002-06-04 |
| Summary: | summary |