Cleared Traditional

K822965 - CETUS CMV IHA

K822965 is an FDA 510(k) clearance for CETUS CMV IHA, manufactured by Cetus Corp.. The device is a Class 2 Immunology device with product code LJO cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K822965 · Cetus Corp. · Immunology device
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Feb 1983
Decision
131d
Days
Class 2
Risk

K822965 is an FDA 510(k) clearance for the CETUS CMV IHA. Classified as Antigen, Iha, Cytomegalovirus (product code LJO), Class II - Special Controls.

Submitted by Cetus Corp. (Mchenry, US). The FDA issued a Cleared decision on February 15, 1983 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3175 - 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 Cetus Corp. devices

FDA 510(k) Submission Details - K822965

510(k) Number K822965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1982
Decision Date February 15, 1983
Days to Decision 131 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 105d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJO Device Classification - Class 2, Special Controls

Product Code LJO Antigen, Iha, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.