The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Benzodiazepine Enzyme Immunoassay.
| Device ID | K032365 |
| 510k Number | K032365 |
| Device Name: | BENZODIAZEPINE ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| 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 | JXM |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-31 |
| Decision Date | 2003-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07601360 | K032365 | 000 |
| 00811727017116 | K032365 | 000 |
| 00811727017123 | K032365 | 000 |
| 00811727017130 | K032365 | 000 |
| 00811727017147 | K032365 | 000 |
| 00811727017154 | K032365 | 000 |
| 00811727017161 | K032365 | 000 |
| B07601300 | K032365 | 000 |
| B07601310 | K032365 | 000 |
| B07601320 | K032365 | 000 |
| B07601330 | K032365 | 000 |
| B07601340 | K032365 | 000 |
| B07601350 | K032365 | 000 |
| 00811727017109 | K032365 | 000 |