Cleared Traditional

K791282 - ANTI-HUMAN SERUM

K791282 is an FDA 510(k) clearance for ANTI-HUMAN SERUM, manufactured by Diagnostica, Inc.. The device is a Class 1 Immunology device with product code DGQ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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

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

Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5700 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostica, Inc. devices

FDA 510(k) Submission Details - K791282

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 105d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

DGQ Device Classification - Class 1, General Controls

Product Code DGQ Whole Blood Plasma, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.