AUTOFLUOR SYSTEM

Fluorometer

CALIFORNIA IMMUNO DIAGNOSTIC, INC.

The following data is part of a premarket notification filed by California Immuno Diagnostic, Inc. with the FDA for Autofluor System.

Pre-market Notification Details

Device IDK800698
510k NumberK800698
Device Name:AUTOFLUOR SYSTEM
ClassificationFluorometer
Applicant CALIFORNIA IMMUNO DIAGNOSTIC, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJZT  
CFR Regulation Number866.4520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-28
Decision Date1980-05-28

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