UREA NITROGEN TEST

Berthelot Indophenol, Urea Nitrogen

U. S. DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for Urea Nitrogen Test.

Pre-market Notification Details

Device IDK863889
510k NumberK863889
Device Name:UREA NITROGEN TEST
ClassificationBerthelot Indophenol, Urea Nitrogen
Applicant U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
ContactRoy E Speck
CorrespondentRoy E Speck
U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
Product CodeCDL  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-06
Decision Date1986-11-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.