DIA STRIPS SYSTEM

Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)

CALIFORNIA IMMUNO DIAGNOSTIC, INC.

The following data is part of a premarket notification filed by California Immuno Diagnostic, Inc. with the FDA for Dia Strips System.

Pre-market Notification Details

Device IDK831623
510k NumberK831623
Device Name:DIA STRIPS SYSTEM
ClassificationDiazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Applicant CALIFORNIA IMMUNO DIAGNOSTIC, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCDM  
CFR Regulation Number862.1785 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-20
Decision Date1983-07-28

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