The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox C-reactive Protein.
| Device ID | K001009 |
| 510k Number | K001009 |
| Device Name: | RANDOX C-REACTIVE PROTEIN |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, 55 DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Contact | P. Armstrong |
| Correspondent | P. Armstrong RANDOX LABORATORIES, LTD. ARDMORE, 55 DIAMOND ROAD Crumlin, Co. Antrim, GB 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 | 2000-03-29 |
| Decision Date | 2000-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414505992 | K001009 | 000 |
| 00630414475707 | K001009 | 000 |
| 05055273201802 | K001009 | 000 |
| 05055273201796 | K001009 | 000 |
| 05055273201789 | K001009 | 000 |
| 05055273201772 | K001009 | 000 |