510(k) K810043

Device: Goat Anti-herpes Simplex Virus Type I
Applicant: VIBAC CORP.
510(k) number: K810043
Product code: GQM
Decision: Substantially Equivalent (SESE)
Decision date: 1981-05-15
Date received: 1981-01-07
Regulation: 866.3305
Classification name: Antisera, Neutralization, Herpesvirus Hominis
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GQM#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K875367	COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV	Enzo Biochem, Inc.	1988-03-28
K791397	HERPES EIA TEST KIT	Microbiological Assoc.	1979-09-24