The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for C-reactive Protein Latex Kit.
| Device ID | K954447 |
| 510k Number | K954447 |
| Device Name: | C-REACTIVE PROTEIN LATEX KIT |
| 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 | 1995-09-25 |
| Decision Date | 1995-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273201741 | K954447 | 000 |
| 05055273201642 | K954447 | 000 |