Cleared Traditional

HLA CONTROL SERA

K791118 · Calbiochem-Behring Corp. · Hematology
Aug 1979
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K791118 is an FDA 510(k) clearance for the HLA CONTROL SERA, a Test, Leukocyte Typing (Class I — General Controls, product code LGO), submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979, 49 days after receiving the submission on June 15, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7675.

Submission Details

510(k) Number K791118 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1979
Decision Date August 03, 1979
Days to Decision 49 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