The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for C-reactive Protein Immunoturbidimetric Kit & Crp Calibrator.
| Device ID | K953212 |
| 510k Number | K953212 |
| Device Name: | C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-10 |
| Decision Date | 1995-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273201833 | K953212 | 000 |
| 05055273201826 | K953212 | 000 |
| 05055273201819 | K953212 | 000 |
| 05055273201765 | K953212 | 000 |
| 05055273201758 | K953212 | 000 |
| 05055273201734 | K953212 | 000 |