The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Trinidad Ch Vancomycin (vanc), Trinidad Ch Drug 3 Calibrator (drug3 Cal).
| Device ID | K160202 |
| 510k Number | K160202 |
| Device Name: | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE, PO BOX 6101 MS 514 Newark, DE 19711 |
| Contact | Laura J. Duggan |
| Correspondent | Laura J. Duggan SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE, PO BOX 6101 MS 514 Newark, DE 19711 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-28 |
| Decision Date | 2016-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597485 | K160202 | 000 |