ALBUMIN REAGENT SET

Bromcresol Green Dye-binding, Albumin

TECH-NEAL SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Albumin Reagent Set.

Pre-market Notification Details

Device IDK880844
510k NumberK880844
Device Name:ALBUMIN REAGENT SET
ClassificationBromcresol Green Dye-binding, Albumin
Applicant TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont,  IL  60559
ContactArun Sanghavi
CorrespondentArun Sanghavi
TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont,  IL  60559
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-26
Decision Date1988-04-05

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