The following data is part of a premarket notification filed by Bio-analytics Laboratories, Inc. with the FDA for Urea Nitrogen, Kinetic.
Device ID | K810087 |
510k Number | K810087 |
Device Name: | UREA NITROGEN, KINETIC |
Classification | O-phthalaldehyde, Urea Nitrogen |
Applicant | BIO-ANALYTICS LABORATORIES, 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 | 1981-01-13 |
Decision Date | 1981-02-26 |