The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for C-reactive Protein (latex).
| Device ID | K083444 |
| 510k Number | K083444 |
| Device Name: | C-REACTIVE PROTEIN (LATEX) |
| Classification | System, Test, C-reactive Protein |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50416 Indianapolis, IN 46250 -0416 |
| Contact | Kathie J Goodwin |
| Correspondent | Kathie J Goodwin ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50416 Indianapolis, IN 46250 -0416 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-21 |
| Decision Date | 2009-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121184 | K083444 | 000 |
| 04015630925285 | K083444 | 000 |
| 04015630923939 | K083444 | 000 |
| 04015630923274 | K083444 | 000 |
| 04015630923267 | K083444 | 000 |