The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Online Tdm Vancomycin Gen.3.
| Device ID | K152245 |
| 510k Number | K152245 |
| Device Name: | ONLINE TDM Vancomycin Gen.3 |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | ROCHE DIAGNOSTICS OPERATIONS (RDO) 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Barbara Mcwhorter |
| Correspondent | Barbara Mcwhorter ROCHE DIAGNOSTICS OPERATIONS (RDO) 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-10 |
| Decision Date | 2016-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336157800 | K152245 | 000 |
| 07613336121627 | K152245 | 000 |