Cleared Traditional

K963803 - CENTOCOR CA 15-3 RIA MODEL NO. 800-033

K963803 is the FDA 510(k) clearance for CENTOCOR CA 15-3 RIA MODEL NO. 800-033 by Centocor, Inc.. It is a Class 2 Immunology device (product code MOI) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K963803 · Centocor, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
242d
Days
Class 2
Risk

K963803 is an FDA 510(k) clearance for the CENTOCOR CA 15-3 RIA MODEL NO. 800-033. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Centocor, Inc. (Malvern, US). The FDA issued a Cleared decision on May 23, 1997 after a review of 242 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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 Centocor, Inc. devices

Submission Details

510(k) Number K963803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date May 23, 1997
Days to Decision 242 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 104d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOI System, Test, Immunological, Antigen, Tumor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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.