Cleared Traditional

LYMPHOCYTE TYPING, POSITIVE CONTROL

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

About This 510(k) Submission

K761009 is an FDA 510(k) clearance for the LYMPHOCYTE TYPING, POSITIVE CONTROL, a Test, Leukocyte Typing (Class I — General Controls, product code LGO), submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 6, 1977, 155 days after receiving the submission on November 2, 1976. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7675.

Submission Details

510(k) Number K761009 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1976
Decision Date April 06, 1977
Days to Decision 155 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code LGO — Test, Leukocyte Typing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.7675