Cleared Traditional

K770680 - HEMATRAK

K770680 is the FDA 510(k) clearance for HEMATRAK by Geometric Data, Div. Smithkline Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K770680 · Geometric Data, Div. Smithkline Corp. · Hematology device
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Jul 1977
Decision
81d
Days
Class 2
Risk

K770680 is an FDA 510(k) clearance for the HEMATRAK. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Geometric Data, Div. Smithkline Corp. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1977 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 K770680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1977
Decision Date July 01, 1977
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 113d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.