The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for K.d. Colorimetric Blood Urea N2 Test.
| Device ID | K820418 |
| 510k Number | K820418 |
| Device Name: | K.D. COLORIMETRIC BLOOD UREA N2 TEST |
| Classification | O-phthalaldehyde, Urea Nitrogen |
| Applicant | KING DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JGZ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-16 |
| Decision Date | 1982-03-11 |