IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)

Reagent, Russel Viper Venom

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Lac Screen (claims Added To Acl Futura), Il Test Lac Confirm (claims Addad To Acl Futura).

Pre-market Notification Details

Device IDK990302
510k NumberK990302
Device Name:IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
ClassificationReagent, Russel Viper Venom
Applicant INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington,  MA  02173
Product CodeGIR  
CFR Regulation Number864.8950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-01
Decision Date1999-04-08
Summary:summary

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