The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Apolipoprotein B Immunoturbidiemetric Kit.
| Device ID | K950382 |
| 510k Number | K950382 |
| Device Name: | APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT |
| Classification | Turbidimetric Method, Lipoproteins |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Product Code | JHN |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-31 |
| Decision Date | 1995-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273204452 | K950382 | 000 |
| 05055273204391 | K950382 | 000 |
| 05055273204360 | K950382 | 000 |
| 05055273204339 | K950382 | 000 |
| 05051700016889 | K950382 | 000 |