RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540

Enzyme Linked Immunoabsorbent Assay, Rubella

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Rubella Elisa Test System Catalog Number: 4540.

Pre-market Notification Details

Device IDK860145
510k NumberK860145
Device Name:RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
ContactMarylou Panico
CorrespondentMarylou Panico
CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-15
Decision Date1986-07-14

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