Cleared Traditional

K780005 - GOAT ANTI-INFLUENZA ANTISERA (FDA 510(k) Clearance)

Class I Microbiology device.

K780005 · Northeast Biomedical Labs., Inc. · Microbiology device
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Jan 1978
Decision
17d
Days
Class 1
Risk

K780005 is an FDA 510(k) clearance for the GOAT ANTI-INFLUENZA ANTISERA. Classified as Antisera, Hai, Influenza Virus A, B, C (product code GNS), Class I - General Controls.

Submitted by Northeast Biomedical Labs., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 20, 1978 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Northeast Biomedical Labs., Inc. devices

Submission Details

510(k) Number K780005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1978
Decision Date January 20, 1978
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 102d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNS Antisera, Hai, Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.