Cleared Traditional

K964781 - IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMI...

K964781 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMI..., manufactured by Beckman Instruments, Inc.. The device is a Class 1 Immunology device with product code DDS cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K964781 · Beckman Instruments, Inc. · Immunology device
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May 1997
Decision
163d
Days
Class 1
Risk

K964781 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT. Classified as Prealbumin, Fitc, Antigen, Antiserum, Control (product code DDS), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 163 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5060 - 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K964781

510(k) Number K964781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date May 09, 1997
Days to Decision 163 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 104d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

DDS Device Classification - Class 1, General Controls

Product Code DDS Prealbumin, Fitc, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5060
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.