RUBELLA ANTIBODY FLUOROIMMUNOASSAY

Antigen, Ha (including Ha Control), Rubella

INTL. DIAGNOSTIC TECHNOLOGY

The following data is part of a premarket notification filed by Intl. Diagnostic Technology with the FDA for Rubella Antibody Fluoroimmunoassay.

Pre-market Notification Details

Device IDK841174
510k NumberK841174
Device Name:RUBELLA ANTIBODY FLUOROIMMUNOASSAY
ClassificationAntigen, Ha (including Ha Control), Rubella
Applicant INTL. DIAGNOSTIC TECHNOLOGY 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGOL  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-19
Decision Date1984-06-07

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