The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Total Protein (urine).
| Device ID | K951222 |
| 510k Number | K951222 |
| Device Name: | TOTAL PROTEIN (URINE) |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| 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 | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-20 |
| Decision Date | 1996-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597621 | K951222 | 000 |
| 00630414482460 | K951222 | 000 |