The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Emit Ii Plus Oxycodone Assay.
| Device ID | K172910 |
| 510k Number | K172910 |
| Device Name: | Emit II Plus Oxycodone Assay |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Siemens Healthcare Diagnostics Inc. P.O. Box 6101, M/S 514 Newark, DE 19714 -6101 |
| Contact | Alan Haley |
| Correspondent | Alan Haley Siemens Healthcare Diagnostics Inc. P.O. Box 6101, M/S 514 Newark, DE 19714 -6101 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2017-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414238098 | K172910 | 000 |
| 00630414028019 | K172910 | 000 |
| 00630414027937 | K172910 | 000 |
| 00630414027920 | K172910 | 000 |