The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Liquid Assayed Chemistry Control Premium Plus Level 1,2 And Level 3..
| Device ID | K140971 |
| 510k Number | K140971 |
| Device Name: | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | RANDOX LABORATORIES LIMITED 55 DIAMOND RD. Crumlin, Co.antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES LIMITED 55 DIAMOND RD. Crumlin, Co.antrim, GB 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 | 2014-04-16 |
| Decision Date | 2014-12-08 |
| Summary: | summary |