The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,calibrators,controls.
| Device ID | K113139 |
| 510k Number | K113139 |
| Device Name: | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
| Contact | Bernice Lin |
| Correspondent | Bernice Lin Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
| Product Code | DIO |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2011-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07603480 | K113139 | 000 |
| 00811727017840 | K113139 | 000 |
| 00811727017857 | K113139 | 000 |
| 00811727017864 | K113139 | 000 |
| 00811727017871 | K113139 | 000 |
| 00811727017888 | K113139 | 000 |
| 00811727017895 | K113139 | 000 |
| 00811727017901 | K113139 | 000 |
| B07603400 | K113139 | 000 |
| B07603410 | K113139 | 000 |
| B07603420 | K113139 | 000 |
| B07603430 | K113139 | 000 |
| B07603440 | K113139 | 000 |
| B07603450 | K113139 | 000 |
| B07603470 | K113139 | 000 |
| 00811727017833 | K113139 | 000 |