EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550

Test, Antigen, Nuclear, Epstein-barr Virus

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Epstein-barr Virus (ebna-1) Igg Cata. #4550.

Pre-market Notification Details

Device IDK883600
510k NumberK883600
Device Name:EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
ClassificationTest, Antigen, Nuclear, Epstein-barr 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 CodeLLM  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-23
Decision Date1989-05-11

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