Cleared Traditional

K791282 - ANTI-HUMAN SERUM
(FDA 510(k) Clearance)

K791282 · Diagnostica, Inc. · Immunology device
Oct 1979
Decision
99d
Days
Class 1
Risk

K791282 is an FDA 510(k) clearance for the ANTI-HUMAN SERUM. This device is classified as a Whole Blood Plasma, Antigen, Antiserum, Control (Class I - General Controls, product code DGQ).

Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979, 99 days after receiving the submission on July 10, 1979.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5700.

Submission Details

510(k) Number K791282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1979
Decision Date October 17, 1979
Days to Decision 99 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DGQ — Whole Blood Plasma, Antigen, Antiserum, Control
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.5700