SOFTWARE, BLOOD VIRUS APPLICATION

Software, Blood Virus Applications

Sanguin International

The following data is part of a premarket notification filed by Sanguin International with the FDA for Software, Blood Virus Application.

Pre-market Notification Details

Device IDBK980003
510k NumberBK980003
Device Name:SOFTWARE, BLOOD VIRUS APPLICATION
ClassificationSoftware, Blood Virus Applications
Applicant Sanguin International 1020 Sherman Avenue Hamden,  CT  06514
Product CodeMTQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-29
Decision Date1999-09-29

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