Cleared Traditional

K852737 - LACTOPLATE

K852737 is an FDA 510(k) clearance for LACTOPLATE, manufactured by Mackeen Consultants, Ltd.. The device is a Class 1 Immunology device with product code DEG cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K852737 · Mackeen Consultants, Ltd. · Immunology device
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Oct 1985
Decision
120d
Days
Class 1
Risk

K852737 is an FDA 510(k) clearance for the LACTOPLATE. Classified as Lactoferrin, Antigen, Antiserum, Control (product code DEG), Class I - General Controls.

Submitted by Mackeen Consultants, Ltd. (Bethesda, US). The FDA issued a Cleared decision on October 25, 1985 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5570 - 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 Mackeen Consultants, Ltd. devices

FDA 510(k) Submission Details - K852737

510(k) Number K852737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1985
Decision Date October 25, 1985
Days to Decision 120 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 105d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

DEG Device Classification - Class 1, General Controls

Product Code DEG Lactoferrin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5570
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.