The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Modified Enzymatic Bun Reagent.
| Device ID | K872484 |
| 510k Number | K872484 |
| Device Name: | MODIFIED ENZYMATIC BUN REAGENT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | TRACE SCIENTIFIC LTD. 6135 NORTHWEST 167TH ST. NO. E9 Miami Lakes, FL 33015 |
| Contact | William C Riddle |
| Correspondent | William C Riddle TRACE SCIENTIFIC LTD. 6135 NORTHWEST 167TH ST. NO. E9 Miami Lakes, FL 33015 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-24 |
| Decision Date | 1987-08-19 |