The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Precision-multi-sera - Human - Normal And Elevated.
| Device ID | K942458 |
| 510k Number | K942458 |
| Device Name: | PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-24 |
| Decision Date | 1995-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817439020901 | K942458 | 000 |
| 00817439020895 | K942458 | 000 |