HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY

Anti-dna Antibody (enzyme-labeled), Antigen, Control

HYCOR BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hycor Hy.tec/manual Ds-dna Auto-antibody.

Pre-market Notification Details

Device IDK962730
510k NumberK962730
Device Name:HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
ClassificationAnti-dna Antibody (enzyme-labeled), Antigen, Control
Applicant HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove,  CA  92841
ContactMehdi Alem, Ph.d.
CorrespondentMehdi Alem, Ph.d.
HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove,  CA  92841
Product CodeLRM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-01
Decision Date1997-03-07

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