Goat Anti-Herpes Simplex Virus Type I

FDA 510(k) K810043 · Vibac Corp.

Substantially Equivalent

510(k) numberK810043

Submission

Device name
Goat Anti-Herpes Simplex Virus Type I
Applicant
Vibac Corp.
Mchenry, IL, US
Received
January 7, 1981
Decision date
May 15, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GQM – Antisera, Neutralization, Herpesvirus Hominis
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3305
Specialty
Microbiology

Other 510(k)s with product code GQM

510(k)DeviceApplicantDecision
K875367Colorgene Fluorescent DNA Hybridization Test / CMVGQM · Traditional Enzo Biochem, Inc.03/28/1988SE
K791397Herpes Eia Test KitGQM · Traditional Microbiological Assoc.09/24/1979SE

Questions and answers

When was Goat Anti-Herpes Simplex Virus Type I cleared by the FDA?

Goat Anti-Herpes Simplex Virus Type I (K810043) received a 510(k) decision of Substantially Equivalent on May 15, 1981, 128 days after the submission was received.

What is the product code of K810043?

The FDA product code is GQM – Antisera, Neutralization, Herpesvirus Hominis, a Class II (moderate risk) device regulated under 21 CFR 866.3305.