SANDARE BCG ALBUMIN PROCEDURE

Bromcresol Green Dye-binding, Albumin

SANDARE CHEMICAL CO., INC.

The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Bcg Albumin Procedure.

Pre-market Notification Details

Device IDK860684
510k NumberK860684
Device Name:SANDARE BCG ALBUMIN PROCEDURE
ClassificationBromcresol Green Dye-binding, Albumin
Applicant SANDARE CHEMICAL CO., INC. P.O. BOX 3028 Desoto,  TX  75115
ContactJames L Sanders
CorrespondentJames L Sanders
SANDARE CHEMICAL CO., INC. P.O. BOX 3028 Desoto,  TX  75115
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-25
Decision Date1986-03-17

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