EF SYNERGY QUAD MODIFIED

Manual Antimicrobial Susceptibility Test Systems

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Ef Synergy Quad Modified.

Pre-market Notification Details

Device IDK910242
510k NumberK910242
Device Name:EF SYNERGY QUAD MODIFIED
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactAnn Silvius
CorrespondentAnn Silvius
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-22
Decision Date1991-03-05

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