The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Emit Ii Plus Cocaine Metabolite Assay.
| Device ID | K170293 |
| 510k Number | K170293 |
| Device Name: | Emit II Plus Cocaine Metabolite Assay |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-31 |
| Decision Date | 2017-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768014390 | K170293 | 000 |
| 00842768001949 | K170293 | 000 |
| 00842768001932 | K170293 | 000 |
| 00842768023415 | K170293 | 000 |