Cleared Traditional

K810043 - GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I

K810043 is an FDA 510(k) clearance for GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I, manufactured by Vibac Corp.. The device is a Class 2 Microbiology device with product code GQM cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K810043 · Vibac Corp. · Microbiology device
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May 1981
Decision
128d
Days
Class 2
Risk

K810043 is an FDA 510(k) clearance for the GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I. Classified as Antisera, Neutralization, Herpesvirus Hominis (product code GQM), Class II - Special Controls.

Submitted by Vibac Corp. (Mchenry, US). The FDA issued a Cleared decision on May 15, 1981 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vibac Corp. devices

FDA 510(k) Submission Details - K810043

510(k) Number K810043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1981
Decision Date May 15, 1981
Days to Decision 128 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 102d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQM Device Classification - Class 2, Special Controls

Product Code GQM Antisera, Neutralization, Herpesvirus Hominis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.