VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT

Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Varicella Zoster Igg Clin-elisa Test Kit.

Pre-market Notification Details

Device IDK900688
510k NumberK900688
Device Name:VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
ClassificationEnzyme Linked Immunoabsorbent Assay, Varicella-zoster
Applicant CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
ContactHelen Schneider
CorrespondentHelen Schneider
CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
Product CodeLFY  
CFR Regulation Number866.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-13
Decision Date1990-05-15

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