Cleared Traditional

K813513 - AFRICAN GREEN MONKEY BLOOD IN ALSERVERS

K813513 is an FDA 510(k) clearance for AFRICAN GREEN MONKEY BLOOD IN ALSERVERS, manufactured by Dutchland Laboratories, Inc.. The device is a Class 1 Pathology device with product code LHW cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K813513 · Dutchland Laboratories, Inc. · Pathology device
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Dec 1981
Decision
16d
Days
Class 1
Risk

K813513 is an FDA 510(k) clearance for the AFRICAN GREEN MONKEY BLOOD IN ALSERVERS. Classified as Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment (product code LHW), Class I - General Controls.

Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.3720 - 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

FDA 510(k) Submission Details - K813513

510(k) Number K813513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1981
Decision Date December 31, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 77d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

LHW Device Classification - Class 1, General Controls

Product Code LHW Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
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.