IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530

Antibody Igm,if, Cytomegalovirus Virus

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Igm Cmv Clin-elisa(tm) Test System Number: 5530.

Pre-market Notification Details

Device IDK872942
510k NumberK872942
Device Name:IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
ClassificationAntibody Igm,if, Cytomegalovirus Virus
Applicant CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
ContactMarylou Panico
CorrespondentMarylou Panico
CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
Product CodeLKQ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-27
Decision Date1988-01-11

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