The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Microalbumin.
| Device ID | K002674 |
| 510k Number | K002674 |
| Device Name: | RANDOX MICROALBUMIN |
| Classification | Albumin, Fitc, Antigen, Antiserum, Control |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Product Code | DDZ |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-28 |
| Decision Date | 2000-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273209259 | K002674 | 000 |
| 05055273204568 | K002674 | 000 |
| 05055273204551 | K002674 | 000 |
| 05055273204544 | K002674 | 000 |
| 05055273204537 | K002674 | 000 |