Cleared Traditional

ALLO-TYPE HUMAN IMMUNOGLOBULIN-

K841114 · Genetic Testing Institute · Immunology

Jun 1984

Decision

91d

Days

Class 1

Risk

About This 510(k) Submission

K841114 is an FDA 510(k) clearance for the ALLO-TYPE HUMAN IMMUNOGLOBULIN-, a Ng1m(a), Antigen, Antiserum, Control (Class I — General Controls, product code DGX), submitted by Genetic Testing Institute (Mchenry, US). The FDA issued a Cleared decision on June 14, 1984, 91 days after receiving the submission on March 15, 1984. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5065.

Submission Details

510(k) Number	K841114 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 1984
Decision Date	June 14, 1984
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—