The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Prealbumin.
| Device ID | K000661 |
| 510k Number | K000661 |
| Device Name: | RANDOX PREALBUMIN |
| Classification | Prealbumin, Antigen, Antiserum, Control |
| 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 | JZJ |
| CFR Regulation Number | 866.5060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596259 | K000661 | 000 |
| 00630414517704 | K000661 | 000 |