The following data is part of a premarket notification filed by Reference Diagnostics, Inc. with the FDA for Rdi Hs Crp Kit.
| Device ID | K021609 |
| 510k Number | K021609 |
| Device Name: | RDI HS CRP KIT |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 Bedford, MA 01730 |
| Contact | Joseph Lawlor |
| Correspondent | Joseph Lawlor REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 Bedford, MA 01730 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-16 |
| Decision Date | 2002-06-27 |