ANTIBODY TO VARICELLA-ZOSTER VIRUS

Test, Time, Partial Thromboplastin

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Antibody To Varicella-zoster Virus.

Pre-market Notification Details

Device IDK800787
510k NumberK800787
Device Name:ANTIBODY TO VARICELLA-ZOSTER VIRUS
ClassificationTest, Time, Partial Thromboplastin
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGGW  
CFR Regulation Number864.7925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-08
Decision Date1980-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G5229028011 K800787 000
G5229028001 K800787 000

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