The following data is part of a premarket notification filed by Sentinel Ch. Srl with the FDA for Crp Diagnostic Assay.
| Device ID | K050836 |
| 510k Number | K050836 |
| Device Name: | CRP DIAGNOSTIC ASSAY |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | SENTINEL CH. SRL PIAZZA ALBANIA 10 Rome, IT 00153 |
| Contact | Maria E Donawa |
| Correspondent | Maria E Donawa SENTINEL CH. SRL PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | DCK |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2005-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058056681911 | K050836 | 000 |