Cleared Traditional

K812602 - RABBIT COAGULASE PLASMA (FDA 510(k) Clearance)

Class I Microbiology device.

K812602 · Dutchland Laboratories, Inc. · Microbiology device
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Sep 1981
Decision
14d
Days
Class 1
Risk

K812602 is an FDA 510(k) clearance for the RABBIT COAGULASE PLASMA. Classified as Plasma, Coagulase, Human, Horse And Rabbit (product code JTL), Class I - General Controls.

Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2160 - 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 Dutchland Laboratories, Inc. devices

Submission Details

510(k) Number K812602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date September 29, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTL Plasma, Coagulase, Human, Horse And Rabbit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2160
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.