BION HSV1-G OR HSV2-G TEST SYSTEM

Antisera, Cf, Herpesvirus Hominis 1,2

BION ENT., LTD.

The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Hsv1-g Or Hsv2-g Test System.

Pre-market Notification Details

Device IDK881261
510k NumberK881261
Device Name:BION HSV1-G OR HSV2-G TEST SYSTEM
ClassificationAntisera, Cf, Herpesvirus Hominis 1,2
Applicant BION ENT., LTD. 674 BUSSE HWY. Park Ridge,  IL  60068
ContactEdward Nowakowski
CorrespondentEdward Nowakowski
BION ENT., LTD. 674 BUSSE HWY. Park Ridge,  IL  60068
Product CodeGQO  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-24
Decision Date1988-06-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B110HSN35100 K881261 000
B110HSM35300 K881261 000
B110HSG35200 K881261 000
B110HS2G1200 K881261 000
B110HS240120 K881261 000
B110HS1G1200 K881261 000
B110HS130120 K881261 000

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