The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Complement C4.
| Device ID | K000468 |
| 510k Number | K000468 |
| Device Name: | RANDOX COMPLEMENT C4 |
| Classification | Complement C4, Antigen, Antiserum, Control |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Contact | P Armstrong |
| Correspondent | P Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Product Code | DBI |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-11 |
| Decision Date | 2000-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595658 | K000468 | 000 |
| 00630414517742 | K000468 | 000 |
| 05055273201628 | K000468 | 000 |