The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Enzyme Immunoassay, Vancomycin.
| Device ID | K060586 |
| 510k Number | K060586 |
| Device Name: | ENZYME IMMUNOASSAY, VANCOMYCIN |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Dimitris Demirtzoglou |
| Correspondent | Dimitris Demirtzoglou ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. 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 | 2006-03-07 |
| Decision Date | 2006-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630997961 | K060586 | 000 |