The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Methadone Metabolite (eddp) Enzime Immunoassay, Cat. No. 190 (500 Test Kit), No. 191 (5000 Test Kit).
| Device ID | K031797 |
| 510k Number | K031797 |
| Device Name: | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-10 |
| Decision Date | 2003-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07601980 | K031797 | 000 |
| 00811727018083 | K031797 | 000 |
| 00811727018090 | K031797 | 000 |
| 00811727018106 | K031797 | 000 |
| 00811727018113 | K031797 | 000 |
| 00811727018120 | K031797 | 000 |
| 00811727018151 | K031797 | 000 |
| 00811727018168 | K031797 | 000 |
| 00811727018175 | K031797 | 000 |
| 00811727018182 | K031797 | 000 |
| B07601900 | K031797 | 000 |
| B07601910 | K031797 | 000 |
| B07601920 | K031797 | 000 |
| B07601930 | K031797 | 000 |
| B07601940 | K031797 | 000 |
| B07601950 | K031797 | 000 |
| B07601970 | K031797 | 000 |
| 00811727018076 | K031797 | 000 |