Cleared Traditional

K780886 - SYSTEM 6000 AUTOMATED RIA ANALYZER (FDA 510(k) Clearance)

Class I Chemistry device.

K780886 · Beckman Instruments, Inc. · Chemistry device
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Sep 1978
Decision
98d
Days
Class 1
Risk

K780886 is an FDA 510(k) clearance for the SYSTEM 6000 AUTOMATED RIA ANALYZER. Classified as Automated Radioimmunoassay Systems, For Clinical Use (product code LCI), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1978 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Instruments, Inc. devices

Submission Details

510(k) Number K780886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1978
Decision Date September 01, 1978
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCI Automated Radioimmunoassay Systems, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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.