The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits).
| Device ID | K033866 |
| 510k Number | K033866 |
| Device Name: | CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Contact | Cheng-i Lin |
| Correspondent | Cheng-i Lin Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DZK |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-12 |
| Decision Date | 2004-04-07 |
| Summary: | summary |