The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Ammonia.
| Device ID | K030873 |
| 510k Number | K030873 |
| Device Name: | RANDOX AMMONIA |
| Classification | Enzymatic Method, Ammonia |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | Lynne Hamilton |
| Correspondent | Lynne Hamilton RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-20 |
| Decision Date | 2003-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273200270 | K030873 | 000 |
| 05055273200263 | K030873 | 000 |
| 05055273200256 | K030873 | 000 |