Cleared Traditional

K964010 - IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPR...

K964010 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPR..., manufactured by Beckman Instruments, Inc.. The device is a Class 1 Immunology device with product code MSJ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K964010 · Beckman Instruments, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Feb 1997
Decision
126d
Days
Class 1
Risk

K964010 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNO.... Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - 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 - K964010

510(k) Number K964010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date February 10, 1997
Days to Decision 126 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
22d slower than avg
Panel avg: 104d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

MSJ Device Classification - Class 1, General Controls

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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.

Regulatory Peers - MSJ Apolipoproteins

All 30
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K964010.
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
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K992662 · Bayer Corp. · Feb 2000
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
K970314 · Beckman Instruments, Inc. · Apr 1997
NICHOLS APO B CHEMILUMINESCENCE ASSAY
K925702 · Nichols Institute Diagnostics · Dec 1992
IL TEST APOLIPOROTEIN B (APO B)
K923080 · Instrumentation Laboratory CO · Oct 1992
IL TEST APOLIPOPROTEIN A1
K923087 · Instrumentation Laboratory CO · Oct 1992