Cleared Traditional

K811225 - HUMAN BLOOD IN ALSEVER'S (FDA 510(k) Clearance)

Class I Pathology device.

K811225 · Dutchland Laboratories, Inc. · Pathology device
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Jun 1981
Decision
39d
Days
Class 1
Risk

K811225 is an FDA 510(k) clearance for the HUMAN BLOOD IN ALSEVER'S. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.2450 - the FDA pathology 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 K811225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date June 12, 1981
Days to Decision 39 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 77d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
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.