The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Albumin.
| Device ID | K000483 |
| 510k Number | K000483 |
| Device Name: | RANDOX ALBUMIN |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Contact | P Armstrong |
| Correspondent | P Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-14 |
| Decision Date | 2000-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273200034 | K000483 | 000 |