The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Advia Chemistry C-reactive Protein_2, (crp_2) And Calibrators.
| Device ID | K072658 |
| 510k Number | K072658 |
| Device Name: | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS |
| Classification | System, Test, C-reactive Protein |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Philip Liu |
| Correspondent | Philip Liu SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-20 |
| Decision Date | 2008-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597515 | K072658 | 000 |
| 00630414552118 | K072658 | 000 |
| 00630414534244 | K072658 | 000 |