Cleared Traditional

K812367 - GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (FDA 510(k) Clearance)

Class I Immunology device.

K812367 · Dutchland Laboratories, Inc. · Immunology device
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Sep 1981
Decision
20d
Days
Class 1
Risk

K812367 is an FDA 510(k) clearance for the GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD). Classified as Staphylococcus Aureus Somatic Antigens (product code LHT), Class I - General Controls.

Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3700 - the FDA immunology 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 Dutchland Laboratories, Inc. devices

Submission Details

510(k) Number K812367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1981
Decision Date September 09, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHT Staphylococcus Aureus Somatic Antigens
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3700
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.