HERPES IDENT. & TYPING TEST HITT

Antisera, Fluorescent, Herpesvirus Hominis 1,2

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Herpes Ident. & Typing Test Hitt.

Pre-market Notification Details

Device IDK831504
510k NumberK831504
Device Name:HERPES IDENT. & TYPING TEST HITT
ClassificationAntisera, Fluorescent, Herpesvirus Hominis 1,2
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGQL  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-11
Decision Date1983-09-20

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