The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for Urea Nitrogen Test.
Device ID | K863889 |
510k Number | K863889 |
Device Name: | UREA NITROGEN TEST |
Classification | Berthelot Indophenol, Urea Nitrogen |
Applicant | U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
Contact | Roy E Speck |
Correspondent | Roy E Speck U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
Product Code | CDL |
CFR Regulation Number | 862.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-06 |
Decision Date | 1986-11-24 |