The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Nanopia Wide Range C-reactive Protein (crp) Reagent Kit.
| Device ID | K052591 |
| 510k Number | K052591 |
| Device Name: | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | CLINICAL DATA, INC. ONE GATEWAY CENTER, SUITE 411 Newton, MA 02146 |
| Contact | Israel M Stein |
| Correspondent | Israel M Stein CLINICAL DATA, INC. ONE GATEWAY CENTER, SUITE 411 Newton, MA 02146 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-21 |
| Decision Date | 2006-02-09 |
| Summary: | summary |