The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Opiate Enzyme Immunoassay.
| Device ID | K110298 |
| 510k Number | K110298 |
| Device Name: | OPIATE ENZYME IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale, CA 94085 |
| Contact | Bernice Lin |
| Correspondent | Bernice Lin Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale, CA 94085 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-01 |
| Decision Date | 2011-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0760021B0 | K110298 | 000 |
| B0760020B0 | K110298 | 000 |
| 00811727016874 | K110298 | 000 |
| 00811727016867 | K110298 | 000 |