Cleared Traditional

K761008 - LYMPHOCYTE TYPING, NEGATIVE CONTROL

K761008 is an FDA 510(k) clearance for LYMPHOCYTE TYPING, manufactured by Hyland Therapeutic Div., Travenol Laboratories. The device is a Class 1 Hematology device with product code LGO cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K761008 · Hyland Therapeutic Div., Travenol Laboratories · Hematology device
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Apr 1977
Decision
155d
Days
Class 1
Risk

K761008 is an FDA 510(k) clearance for the LYMPHOCYTE TYPING, NEGATIVE 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

FDA 510(k) Submission Details - K761008

510(k) Number K761008 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 113d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

LGO Device Classification - Class 1, General Controls

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.