HSVI - IGG ELISA-KIT

Antisera, Cf, Herpesvirus Hominis 1,2

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Hsvi - Igg Elisa-kit.

Pre-market Notification Details

Device IDK852782
510k NumberK852782
Device Name:HSVI - IGG ELISA-KIT
ClassificationAntisera, Cf, Herpesvirus Hominis 1,2
Applicant CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
ContactMarylou Panico
CorrespondentMarylou Panico
CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
Product CodeGQO  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-01
Decision Date1986-01-21

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