Cleared Traditional

K790713 - ANTISERUM TO HUMAN HEMOPEXIN
(FDA 510(k) Clearance)

K790713 · Kent Laboratories, Inc. · Immunology
Sep 1979
Decision
145d
Days
Class 2
Risk

K790713 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN HEMOPEXIN, a Hemopexin, Antigen, Antiserum, Control (Class II — Special Controls, product code CZX), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979, 145 days after receiving the submission on April 12, 1979. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5490.

Submission Details

510(k) Number K790713 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1979
Decision Date September 04, 1979
Days to Decision 145 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CZX — Hemopexin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5490