Cleared Traditional

K823765 - ANTI SERA TO HUMAN OROSCOMUCOID

K823765 is an FDA 510(k) clearance for ANTI SERA TO HUMAN OROSCOMUCOID, manufactured by Kent Laboratories, Inc.. The device is a Class 1 Immunology device with product code DEX cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K823765 · Kent Laboratories, Inc. · Immunology device
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Dec 1982
Decision
16d
Days
Class 1
Risk

K823765 is an FDA 510(k) clearance for the ANTI SERA TO HUMAN OROSCOMUCOID. Classified as Alpha-1-b-glycoprotein, Antigen, Antiserum, Control (product code DEX), Class I - General Controls.

Submitted by Kent Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5420 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kent Laboratories, Inc. devices

FDA 510(k) Submission Details - K823765

510(k) Number K823765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1982
Decision Date December 30, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 105d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

DEX Device Classification - Class 1, General Controls

Product Code DEX Alpha-1-b-glycoprotein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5420
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.