Cleared Traditional

SDI PREPAX DILUKIT M. (K851320) - FDA 510(k) Clearance

Class I Hematology device.

K851320 · Scientific Distributors, Inc. · Hematology device
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Jul 1985
Decision
94d
Days
Class 1
Risk

K851320 is an FDA 510(k) clearance for the SDI PREPAX DILUKIT M.. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Scientific Distributors, Inc. (Norwood, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8200 - the FDA hematology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K851320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1985
Decision Date July 05, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 113d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIF Diluent, Blood Cell
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8200
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.