Cleared Traditional

BLOOD-SMEARING INSTRUMENT (MINIPREP TM) (K760007) - FDA 510(k) Clearance

Class I Hematology device.

K760007 · Geometric Data, Div. Smithkline Corp. · Hematology device
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Sep 1976
Decision
87d
Days
Class 1
Risk

K760007 is an FDA 510(k) clearance for the BLOOD-SMEARING INSTRUMENT (MINIPREP TM). Classified as Spinner, Slide, Automated (product code GKJ), Class I - General Controls.

Submitted by Geometric Data, Div. Smithkline Corp. (Mchenry, US). The FDA issued a Cleared decision on September 3, 1976 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5850 - 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: 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 Geometric Data, Div. Smithkline Corp. devices

Submission Details

510(k) Number K760007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1976
Decision Date September 03, 1976
Days to Decision 87 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 113d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GKJ Spinner, Slide, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.5850
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.