VISIBLE-HERPES TM TEST SYSTEM

Antisera, Cf, Herpesvirus Hominis 1,2

ISOLAB, INC.

The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Visible-herpes Tm Test System.

Pre-market Notification Details

Device IDK854712
510k NumberK854712
Device Name:VISIBLE-HERPES TM TEST SYSTEM
ClassificationAntisera, Cf, Herpesvirus Hominis 1,2
Applicant ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
ContactLoren F Hazelwood
CorrespondentLoren F Hazelwood
ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
Product CodeGQO  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-11-22
Decision Date1986-05-20

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