The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche-creactive Protein (latex).
| Device ID | K073277 |
| 510k Number | K073277 |
| Device Name: | ROCHE-CREACTIVE PROTEIN (LATEX) |
| Classification | System, Test, C-reactive Protein |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kerwin L Kaufman |
| Correspondent | Kerwin L Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-21 |
| Decision Date | 2008-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630927029 | K073277 | 000 |
| 04015630913633 | K073277 | 000 |