The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Randox Urinalysis Controls, Levels 1 And 2.
| Device ID | K110846 |
| 510k Number | K110846 |
| Device Name: | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN Crumlin Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN Crumlin Antrim, GB Bt29 4qy |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-28 |
| Decision Date | 2011-09-30 |