The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Methadone Enzyme Immunoassay.
| Device ID | K023317 |
| 510k Number | K023317 |
| Device Name: | METHADONE ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-03 |
| Decision Date | 2002-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07601110 | K023317 | 000 |
| B07601100 | K023317 | 000 |
| 00811727017031 | K023317 | 000 |
| 00811727017024 | K023317 | 000 |