The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit).
| Device ID | K020763 |
| 510k Number | K020763 |
| Device Name: | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-07 |
| Decision Date | 2002-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07600310 | K020763 | 000 |
| B07600300 | K020763 | 000 |
| 00811727017765 | K020763 | 000 |
| 00811727017758 | K020763 | 000 |