CHOLERA SMART(TM)

Antiserum, Vibrio Cholerae, All Varieties

NEW HORIZONS DIAGNOSTICS CO.

The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Cholera Smart(tm).

Pre-market Notification Details

Device IDK932622
510k NumberK932622
Device Name:CHOLERA SMART(TM)
ClassificationAntiserum, Vibrio Cholerae, All Varieties
Applicant NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia,  MD  21045
ContactJohn Tartal
CorrespondentJohn Tartal
NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia,  MD  21045
Product CodeGSQ  
CFR Regulation Number866.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-01
Decision Date1995-06-27

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