The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Sodium Test Kit And Eletrolyte Cal 1 And 2.
| Device ID | K043268 |
| 510k Number | K043268 |
| Device Name: | SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 |
| Classification | Uranyl Acetate/zinc Acetate, Sodium |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | P Armstrong |
| Correspondent | P Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | CEI |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-26 |
| Decision Date | 2005-02-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273209310 | K043268 | 000 |
| 05055273204704 | K043268 | 000 |
| 05055273204698 | K043268 | 000 |