The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for 6-acetylmorphine Enzyme Immunoassay With 6-acetylmorphine Calibrators And Controls.
| Device ID | K101195 |
| 510k Number | K101195 |
| Device Name: | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-29 |
| Decision Date | 2010-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727018298 | K101195 | 000 |
| 00811727018281 | K101195 | 000 |
| 00811727018274 | K101195 | 000 |
| 00811727018267 | K101195 | 000 |
| 00811727018250 | K101195 | 000 |
| 00811727018243 | K101195 | 000 |
| 00811727018236 | K101195 | 000 |
| 00811727018229 | K101195 | 000 |
| 00811727018212 | K101195 | 000 |