510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Test, Qualitative, For Hla, Non-diagnostic

ROCHE BIOMEDICAL LABORATORIES, INC.

The following data is part of a premarket notification filed by Roche Biomedical Laboratories, Inc. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK910012
510k NumberBK910012
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationTest, Qualitative, For Hla, Non-diagnostic
Applicant ROCHE BIOMEDICAL LABORATORIES, INC. 112 Orange Drive Elon College,  NC  27244
Product CodeMZI  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-16
Decision Date1992-01-06

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