The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Colorimetric Bun Reagent Kit.
| Device ID | K871651 |
| 510k Number | K871651 |
| Device Name: | COLORIMETRIC BUN REAGENT KIT |
| Classification | Berthelot Indophenol, Urea Nitrogen |
| Applicant | BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
| Contact | Roy, Ph.d. |
| Correspondent | Roy, Ph.d. BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
| Product Code | CDL |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-05-12 |