The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071.
| Device ID | K021887 |
| 510k Number | K021887 |
| Device Name: | CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-07 |
| Decision Date | 2002-08-15 |
| Summary: | summary |