The following data is part of a premarket notification filed by Connecticut Diagnostics, Ltd. with the FDA for Blood Urea Nitrogen Reagent.
Device ID | K792362 |
510k Number | K792362 |
Device Name: | BLOOD UREA NITROGEN REAGENT |
Classification | O-phthalaldehyde, Urea Nitrogen |
Applicant | CONNECTICUT DIAGNOSTICS, LTD. 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 | 1979-11-21 |
Decision Date | 1979-12-06 |