RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT

Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control

REAGENTS APPLICATIONS, INC.

The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem (tm) Spia (tm) - Acid Glycoprotein Reagent.

Pre-market Notification Details

Device IDK904175
510k NumberK904175
Device Name:RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
ClassificationAlpha-1-acid-glycoprotein, Antigen, Antiserum, Control
Applicant REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego,  CA  92111 -1203
ContactNorbert Neumann
CorrespondentNorbert Neumann
REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego,  CA  92111 -1203
Product CodeLKL  
CFR Regulation Number866.5420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-11
Decision Date1990-11-13

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