Cleared Traditional

K761009 - LYMPHOCYTE TYPING, POSITIVE CONTROL (FDA 510(k) Clearance)

Class I Hematology device.

K761009 · Hyland Therapeutic Div., Travenol Laboratories · Hematology device
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Apr 1977
Decision
155d
Days
Class 1
Risk

K761009 is an FDA 510(k) clearance for the LYMPHOCYTE TYPING, POSITIVE CONTROL. Classified as Test, Leukocyte Typing (product code LGO), Class I - General Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 6, 1977 after a review of 155 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7675 - 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.

View all Hyland Therapeutic Div., Travenol Laboratories devices

Submission Details

510(k) Number K761009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1976
Decision Date April 06, 1977
Days to Decision 155 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 113d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGO Test, Leukocyte Typing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7675
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.